PERFORMANCE AUDIT
ARIZONA RADIATION REGULATORY AGENCY
RADIATION REGULATORY HEARING BOARD
Report to the Arizona Legislature
By the Auditor General
October 1995
Report # 95- 8
DOUGLAS R. NORTON, CPA
AUDITOR GENERAL
STATE OF ARIZONA
OFFICE OF THE DEBRA K. DAVENPORT, CPA
DEPUTIIUDITOIIGLNLIIAL
Members of the Arizona Legislature
The Honorable Fife Symington, Governor
Mr. Aubrey V. Godwin, Director
Arizona Radiation Regulatory Agency
Dr. James Woolfenden, Chairman
Radiation Regulatory Hearing Board
Transmitted herewith is a report of the Auditor General, A Performance Audit
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory
Hearing Board. This report is in response to a May 5, 1993, resolution of the
Joint Legislative Audit Committee. The performance audit was conducted as
part of the sunset review set forth in A. R. S. 5941- 2951 through 41- 2957.
The report addresses the Agency's current inspection backlog for x- ray and
mammography machines. Reasons for this backlog include inefficient use of
staff resources and ineffective scheduling of inspections. For example, x- ray
and mammography machine inspectors spend an average of only one day a
week performing inspections. We recommend that Agency management shift
non- inspection duties from inspectors, which would allow them to spend more
time performing inspections. We also recommend that the Agency take
stronger and more timely enforcement action against radioactive materials
violations. We reviewed 81 cases with violations and found that the Agency
took some form of enforcement action in only 3 ( 4 percent) of those cases. The
Agency's inability to assess civil penalties due to a discrepancy within its rules
partially contributes to the limited enforcement. The report also presents other
2910 NORTH 44rH STREET . SUITE 410 . PHOENIX, ARIZONA 85018 I ( 602) 553- 0333 1 FAX ( 602) 553- 0051
Page - 2-
October 31, 1996
pertinent information regarding the statutes of the Southwestern Low- Level
Radioactive Waste Disposal Compact and alternatives for disposing of low- level
radioactive waste.
Finally, the report also addresses the statutorily mandated Sunset Factors for
the Radiation Regulatory Hearing Board.
My staff and I will be pleased to discuss or clarlfy items in the report.
This report will be released to the public on November 1, 1995.
Sincerely,
DO&& R. Norton
~ uditorG eneral
Enclosure
SUMMARY
The Office of the Auditor General has conducted a performance audit and sunset review
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing Board,
pursuant to a May 5,1993, resolution of the Joint Legislative Audit Committee. This audit
was conducted as part of the sunset review set forth in A. R. S. 9541- 2951 through 41- 2957.
The Arizona Radiation Regulatory Agency ( ARRA) is responsible for protecting the pub-lic
health, safety, and welfare by regulating the use and sources of radiation. ARRA ac-complishes
this responsibility by:
E Licensing and inspecting radioactive materials such as radioactive isotopes used in
the medical profession and gauges used to determine material content and density;
Registering and inspecting x- ray and mammography machines;
E Coordinating emergency response activities for any incidents, accidents, or emergen-cies
involving radiation in the State including the Palo Verde Nuclear Generating Sta-tion;
and
E Conducting laboratory functions to detect radiation levels in the State's air, water, and
soil.
Additionally, the Agency and its Director perform administrative and enforcement du-ties
assigned to the State by the Southwestern Low- Level Radioactive Waste Disposal
Compact.
The Radiation Regulatory Hearing Board, consisting of five appointed members, serves
as an independent check on the actions taken by the Agency. Licensees, registrants, or
individuals who wish to appeal ARRA actions may do so through the Board. Because the
Board has not met in the past two fiscal years, our work on the Board was limited to a
review and preparation of sunset factors ( see pages 33 through 35).
Failure to Perform Timely
X- Ray Inspections Threatens
Public Health and Safety
( See pages 5 through 13)
ARRA inspections protect the public from unnecessarily high and dangerous exposure to
man- made radiation and its detrimental health effects. However, the Agency currently
faces nearly a 30 percent inspection backlog for x- ray tubes, and over a 77 percent backlog
for mammography tubes.(') Beyond this backlog, several extreme examples of overdue
inspections exist. For example, two separate mammography machines have awaited in-spection
for two and five years, respectively. Similarly, a dental facility is almost four
years overdue for inspection.
Several reasons, including inefficient use of staff resources and ineffective scheduling of
inspections, contribute to ARRA's inability to meet its inspection schedule. For example,
x- ray machine inspectors, including mammography inspectors, spend an average of only
one day per week performing inspections. Much inspector time is consumed with admin-istrative
and registration activities that support staff could easily perform. Additionally,
ARRA's self- imposed mandate to conduct unannounced inspections wastes significant
time because inspectors arrive at facilities during times when machines are being heavily
used or when facilities are closed. Several states report that announced inspections re-duce
wasted time and, because of the nature of inspections, do not decrease their effec-tiveness.
Finally, for ARRA to address its inspection backlog and meet current inspection sched-ules
for x- ray and mammography machines, inspectors should increase the number of
machines they inspect. Several states, including Wisconsin, Oregon, and Louisiana, re-port
a much higher inspection rate per inspector than that achieved by ARRA inspectors.
Our analysis shows that the Agency can meet its inspection workload if inspectors per-form
a minimum average of 450 inspections per year, a rate comparable to that achieved
in other states.
Radioactive Materials
Enforcement Needs
Improvement
( See pages 15 through 22)
The dangerous nature of radioactive materials and the requirement that users adhere to
strict safety and administration policies and procedures demands a strong and consistent
enforcement stance. However, ARRA's untimely response to violations endangers the
' Tubes are the parts of x- ray machines that emit x- rays. Each machine may have more than one tube
and each tube requires inspection.
public health and safety. For example, even though prompt notification and correction of
violations is important, in nearly half of its cases, ARRA takes too long to notify licensees
of violations, gives the licensees too lenient a deadline to respond to the violation, and
then takes no action when over one- quarter of the licensees fail to respond by the dead-line.
In addition to untimely notification, ARRA rarely takes enforcement action when a viola-tion
occurs. Historically, ARRA has relied on civil penalties to enforce compliance with
its rules. From June 1992 through November 1993, the Agency assessed civil penalties
against 11 licensees. However, ARRA discovered a discrepancy within its rules govern-ing
civil penalties and the Attorney General advised the Agency to cease using civil pen-alties
until it could correct the discrepancy. As a result, several violations that merited
civil penalties, including at least 10 licensees with repeat violations and over 20 late lic-ensee
responses to notices of violation, were not assessed civil penalties.
The Agency's reluctance to use other available enforcement options further compounds
this problem. Statute and rule provides a range of enforcement actions that the agency
does not use, including license modification, informal hearings, injunctions, radiation
source impoundment, and license suspension or revocation. We reviewed 81 cases with
violations and found ARRA took some form of enforcement action in only 3 ( 4 percent) of
those cases.
ARRA's lenient enforcement philosophy partially contributes to its untimely and inad-equate
enforcement within the radioactive materials program. Both management and staff
display a preference to avoid strong enforcement actions, even when statute mandates
such actions.
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Table of Contents
Page
Arizona Radiation Reaulatory Aaencv
Introduction and Background ............................................................... 1
Finding I: Failure to Perform Timely X- Ray
Inspections Threatens Public
Health and Safety ........................................................................... 5
Inspections of Man- Made Radiation
Sources Important ....................................................................................................... 5
Inspections Backlog
Plagues ARRA ............................................................................................................. 6
Poor Management of Staff
Resources Leads to Backlog ...................................................................................... 7
ARRA Could Perform
Many More Inspections .............................................................................................. 11
Recommendations ....................................................................................................... 13
Finding II: Radioactive Materials
Enforcement Needs Improvement ................................................... 15
Importance of Strong
Enforcement Program ................................................................................................. 15
Violation Notification
Is Not Timely ............................................................................................................... 16
RAM Enforcement
Is Not Adequate .......................................................................................................... 19
Lenient Philosophy Contributes
to Weak, Untimely Enforcement ............................................................................... 21
Recommendations ....................................................................................................... 22
Table of Contents
Pane
Arizona Radiation Requlatorv Aqencv ( con't)
Other Pertinent Information .............................................................. 23
History of Low- Level
Radioactive Waste ....................................................................................................... 23
Current Status of
Southwestern Compact ............................................................................................... 24
Impact and Alternatives ............................................................................................. 25
Sunset Factors ....................................................................................... 27
Radiation Requlaton, Hearinq Board
Introduction and Background ............................................................... 31
Sunset Factors ....................................................................................... 33
Agency Response
Tables & Figure
Table 1 Overdue X- Ray Inspections
According to ARRA's Inspections
Time Frame as of April 14, 1995 ..................................................... 6
Table 2
Table 3
Table 4
Figure 1
X- Ray and Mammography Tube Ins ections
Performed and Percentage of Time 2' pent on
Inspections Per Inspector, Fiscal Year 1994 ................................... 10
Average Number of X- Ray and
Mammograph Tubes Inspected
Per Inspector, $ i scal Year 1994 ....................................................... 12
Violation Notice and Licensee
Response Time Frames .................................................................... 18
Time Allocation by X- Ray/
Mammography Inspectors ............................................................. 8
INTRODUCTION AND BACKGROUND
The Office of the Auditor General has conducted a performance audit and sunset review
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing Board,
pursuant to a May 5,1993, resolution of the Joint Legislative Audit Committee. This audit
was conducted as part of the sunset review as set forth in A. R. S 5541- 2951 through 41-
2957.
ARRA and Hearing Board
Responsibilities
In 1980, the Legislature established the Arizona Radiation Regulatory Agency ( ARRA),
which replaced the Arizona Atomic Energy Commission. By creating ARRA, the Legisla-ture
wished to:
", . . protect the public health and safety by regulating the use and sources of
radiation. . . ."
ARRA is authorized to regulate man- made sources of radiation except those used by
federal agencies and certain nuclear reactors. Statutes provide authority for ARRA to
license or register such radiation sources, conduct inspections to ensure adequate compli-ance
with agency rules, and assess fees to registrants and licensees. Additionally, ARRA
has entered a special agreement with the Nuclear Regulatory Commission ( NRC) to con-trol
radioactive source materials, small quantities of special nuclear material, and radio-active
by- products from reactors. The agreement allows Arizona to provide local response
to radioactive materials emergencies as well as charge fees that are lower than NRC rates
to the State's radioactive materials users. The agreement also requires Arizona to follow
NRC regulations.
The Agency's additional statutory responsibilities include monitoring off- site radiation
in the air, water, and soil surrounding fixed nuclear facilities; responding to incidents,
accidents, and emergencies involving radiation; and performing administrative and en-forcement
duties related to the Southwestern Low- Level Radioactive Waste Disposal Com-pact,
to which Arizona, California, North Dakota, and South Dakota belong.
The Radiation Regulatory Hearing Board, consisting of five appointed members, is re-sponsible
for conducting hearings involving ARRA enforcement action appeals. The Board
may also review rules and regulations promulgated by ARRA and make recommenda-tions
to the Agency and the Legislature.
Organization
ARRA oversees five programs:
Radioactive Materials ( 4.5 FTEs) - This program oversees the licensing of 290 medi-cal,
industrial, and academic users of radioactive materials. For example, ARRA regu-lates
hospitals that use radioactive isotopes to perform diagnostic procedures and con-struction
companies that use gauges to determine material density. Program inspec-tors
conduct periodic site inspections, involving a review of policies and procedures,
treatment records, and material storage records, to ensure that licensees follow proper
techniques for the use, storage, and shipment of radioactive materials.
X- ray, Mammography, and Non- Ionizing Radiation ( 7.5 FTEs) - This program reg-isters
and periodically inspects 6,960 x- ray ( ionizing radiation) producing machines,
including medical, dental, and industrial radiography machines. Legislation adopted
in 1992 specifically requires annual inspection of the 210 registered, x- ray producing
mammography machines. This program also licenses and inspects non- ionizing radia-tion
sources, such as lasers and tanning beds.
Although the term " radiation" is very broad and includes such things as light and radio
waves, it is most often used to mean " ionizing" radiation, which is radiation that can
produce charged particles (" ions") in materials that it strikes. Ionizing radiation can
present a health hazard to the public. Non- ionizing radiation may also pose a health
risk, although the extent of this risk is not well known or documented and is more
inconclusive than its ionizing counterpart.
Environmental Surveillance Laboratory ( 7 FTEs) - The lab maintains surveillance
over radiation levels near Palo Verde Nuclear Generating Station ( PVNGS), as well as
other areas such as the Navajo Reservation, where radiation levels in the water have
been notably high. Surveillance includes the sampling of air, water, and soil. This
program also provides public information and technical assistance in assessing radon
in Arizona.
Emergency Response ( 2 FTEs) - The Emergency Response program provides tech-nical
assistance to handle any incidents, accidents, or emergencies involving radiation
or sources of radiation within the State. The program also prepares for and partici-pates
in off- site radiation emergency response at PVNGS. Additionally, the program
provides first response training for police, fire, and medical personnel who may re-spond
to accidents.
Medical Radiologic Technology Board of Examiners ( MRTBE) ( 2 FTEs) - MRTBE
certifies operators of medical radiologic equipment by requiring minimum training
and experience.
Budget and Personnel
ARRA's operating budget consists of both appropriated and nonappropriated funds. The
Agency expended over $ 1.5 million in appropriated funds and over $ 270,000 in federal
funds in fiscal year 1994- 95. The $ 1.5 million in appropriated funds represents approxi-mately
$ 1 million from the general fund, $ 399,000 from the Nuclear Emergency Manage-ment
Fund ( NEMF), and $ 102,000 from the State Radiologic Technology Certification
Fund. The Legislature established the NEMF to fund Arizona's nuclear generating sta-tion
emergency response activities. The consortium that operates PVNGS reimburses the
State for amounts appropriated to this fund by the Legislature. The State Radiologic Tech-nology
Certification Fund reflects fees radiology technicians pay to become certified by
the State.
In addition to the FTE numbers indicated for each program, the Agency is authorized 5
FTEs for administration/ support staff and 1 FTE for the Director, for an authorized total
of 29 FTEs. Each program within the Agency reports to a program manager, with the
exception of the radioactive materials ( RAM) and x- ray programs, which are managed by
a single program manager.
Audit Scope
This audit focuses on the need for the Arizona Radiation Regulatory Agency and its ef-forts
to protect the public health and safety from dangers associated with sources of ra-diation
and their use. We also performed limited work on the Radiation Regulatory Hearing
Board which is found in the sunset factors. The Medical Radiologic Technology Board
was not reviewed as part of this audit since it is scheduled for sunset review as part of the
1997 audit cycle.
Our work included a review of the Agency's ability to perform timely inspections of x-ray
machines and radioactive materials, adequacy and timeliness of all enforcement ac-tions
it takes, ability to respond effectively to radiation emergencies, complaint handling,
and current status of the Southwestern Compact for Low- Level Radioactive Waste dis-posal.
Additionally, we contacted ten states, the Conference for Radiation Control Pro-gram
Directors ( CRCPD), and the Nuclear Regulatory Commission.(')
While our work found problems, we also found that ARRA is performing well in some
areas. Unlike x- ray inspections, ARRA performs radioactive materials inspections in a
timely manner. Additionally, while we found problems in radioactive materials license
We contacted radiation officials in states with a similar number of registered x- ray tubes and/ or an
agreement with the Nuclear Regulatory Commission to control radioactive source materials. States
contacted were North Carolina, Minnesota, Maryland, Oregon, Tennessee, Louisiana, Oklahoma, Wis-consin,
Colorado, and Washington.
enforcement, we found minimal problems pertaining to x- ray enforcement. Also, we de-termined
that the Agency responds adequately to radiation emergencies and/ or inci-dents
as demonstrated by its response to a Tucson incident, reviews it has received on
past Palo Verde Nuclear Generating Station response exercises, and previous Auditor
General and federal inspection comments regarding the Agency's response abilities.
Our report presents findings and recommendations in two areas:
The need for improved productivity in ARRA's x- ray/ mammography program in
order to eliminate inspection backlogs.
H The need for more frequent, timely, and aggressive enforcement actions against lic-ensees
who violate radioactive materials regulations.
In addition to these audit areas, we present other pertinent information concerning the
status of the Southwestern Low Level Radioactive Waste Disposal Compact and alterna-tives
for disposing low- level radioactive waste. This report also contains responses to the
12 Sunset Review Factors for the Agency ( see pages 27 through 30) and for the Radiation
Regulatory Hearing Board ( see pages 33 through 35).
The findings in this report are similar to those in our previous report on the Radiation
Regulatory Agency and Radiation Regulatory Hearing Board which was issued in No-vember
1984. That audit found that the Agency did not conduct all its inspections in a
timely manner, it could take stronger or more timely enforcement actions, and that the x-ray
machine registration and fee collection process could be improved. The report also
noted that the Agency had not received sufficient funding from the Nuclear Emergency
Management Fund ( NEMF) to finance its costs relating to Palo Verde Nuclear Generating
Station activities.
This audit was conducted in accordance with government auditing standards.
The Auditor General and staff express appreciation to the Director, staff, and board mem-bers
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing
Board for their cooperation and assistance throughout the audit.
FINDING I
FAILURE TO PERFORM TIMELY X- RAY
INSPECTIONS THREATENS PUBLIC HEALTH
AND SAFETY
X- ray machine ( including mammography machine) inspections should occur at regular
intervals to protect the public from unnecessary radiation exposure. However, nearly 30
percent of x- ray tube and over 77 percent of' mammography tube inspections are past
due. Because staff time and activities are poorly managed, inspectors spend an average of
only one day a week performing inspections. ARRA's management should strive to meet
other states' productivity levels by reducing staff time spent on tasks other than inspec-tions,
holding inspectors accountable for number of inspections performed, and schedul-ing
inspections more efficiently.
ARRA's 5 x- ray inspectors conduct inspections of 3,393 facilities with registered x- ray
tubes. Such facilities include medical, dental, veterinary, and chiropractic offices; hospi-tals;
and industrial facilities. During inspections, inspectors monitor the amount of radia-tion
emitted from each x- ray tube, the adequacy of radiation barriers such as walls, and
the quality of the x- ray images taken. Additionally, ARRA has trained 2 inspectors to
perform inspections of mammography machines at an additional 156 facilities. These in-spections
must conform to the United States Food and Drug Administration ( FDA) stan-dards.(')
Inspections of Man- Made
Radiation Sources Important
ARRA inspections are necessary to protect the public from unnecessarily high and dan-gerous
exposure to ionizing radiation and its detrimental health effects. Even though x-ray
inspections yield nearly a 91 percent compliance rate, the health threat posed by tubes
that emit too much radiation mandates a comprehensive and timely inspection program.
According to the National Research Council, ionizing radiation's " well demonstrated late
effects include the induction of cancer, genetically determined ill- health, developmental
abnormalities, and some degenerative diseases such as cataracts." c2)
' ARRA has a contract with the FDA to perform inspections in accordance with the Mammography
Quality Standards Act of 1992. Such inspections also satisfy Arizona statutory requirements for
mammography machine inspections.
( 2) Health Effects of Exposure to Ionizing Radiation, National Research Council, National Academy Press,
Washington, D. C., 1990.
Ensuring the safety of x- ray tubes is critical since the healing arts ( x- ray and nuclear medi-cine)
represent approximately 83 percent of the U. S. population's total exposure to man-made
ionizing radiation. Also, in recent years, the importance of mammography inspec-tions
has been increasingly stressed due to the large number of women ( one in eight) who
develop breast cancer over the course of a lifetime.
lnspections Backlog
Plagues ARRA
ARRA fails to conduct x- ray and mammography inspections in a timely manner. Inspec-tions
are required at regular intervals established by the Agency itself and by statute.
Nonetheless, hundreds of ARRA's registered x- ray and mammography tubes are over-due
for inspection.
X- ray inspections far behind schedule - ARRA does not keep current with its own schedule
for registered x- ray tube inspections. This schedule requires that inspections occur at regu-lar
intervals from two to four years based on the type of facility where the machine is
used. However, nearly 30 percent of x- ray tube inspections are late according to ARRA's
timetable for inspections, as shown in Table 1.
Table 1
Overdue X- Ray lnspections According to
ARRA's lnspections Time Frame
as of April 14,1995
Hospital Every Two Years 1,036 575 55.5%
Medical
Educational Every Three Years 1,796 528 29.4%
Chiropractic
Dental
Veterinary
Industrial
Podiatry
Total
Every Four Years
Source: Auditor General analysis of ARRA database as of Apnl14,1995.
Our analysis also found many extreme examples of overdue inspections, including:
A Sierra Vista dental facility that is almost four years overdue for inspection. Since
the inspection due date, the facility has taken an estimated 63,200 x- rays.
W Two Tucson hospitals that were almost three years overdue for inspection. Since our
initial analysis, ARRA subsequently inspected one hospital and found that one
machine's radiation filtration was inadequate, resulting in excessive radiation expo-sure.
An Ajo dental facility that went 17.7 years between inspections. Even though this
facility is open only twice a month, which may warrant a more lenient inspection
schedule, ARRA's director indicated the facility should be inspected every 8 to 12
years.
Mammography inspections also overdue - Like other types of x- ray inspections, many
mammography inspections are also past due. Since September 1992, state statute has re-quired
yearly inspections of mammography machines. ( Previously, mammography in-spections
occurred as part of ARRA's routine inspection of x- ray facilities.) Nonetheless,
ARRA has failed to perform these inspections as required. One- hundred sixty- one of the
208 registered mammography tubes ( 77 percent) are overdue for inspection, with 72 tubes
( 35 percent) overdue by more than one year. Extreme examples of overdue inspections
also exist. For instance, ARRA has not inspected a mammography machine in a rural
hospital for over three years and a Maricopa County gynecologisl!~ machine for over six
years. Since their last inspections, an estimated 19,500 and 45,460 mammography expo-sures
have occurred at these facilities.
Poor Management
of Staff Resources
Leads to Backlog
Management's failure to maximize the time inspectors devote to inspections contributes
to the current x- ray inspections backlog. ARRA inspectors currently devote less than 20
percent of their time to inspections, instead devoting time to administrative tasks. Addi-tionally,
management's failure to hold inspectors accountable for the quantity or quality
of inspections further affects the number of inspections performed. Furthermore, the ab-sence
of advanced scheduling of x- ray inspections thwarts the number of inspections that
can be performed.
Small percentage of time dedicated to inspections - Inspectors dedicate few hours to
inspections, thus contributing to inspection backlogs. As shown in Figure 1 ( see page 8),
x- ray and mammography machine inspectors spend 20 percent of their time, or only one
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40 percent of her time handling administrative duties that should be performed by
this manager. These duties include writing contracts, writing employee evaluations,
and reviewing inspections completed by other inspectors. Therefore, this inspector
spent only 19 percent of her time conducting inspections during the 21- month period
ending March 31,1995. If the program manager resumed performing these adminis-trative
duties, this inspector could spend more time performing inspections.
Subsequent conversations with the program manager and the Director did not ad-equately
explain why the program manager spends little time administering the x- ray
program he is charged with overseeing. Although the program manager explained he
has additional duties involving power line siting and the Southwestern Low- Level
Radioactive Waste Compact, these tasks should not detract from his primary respon-sibilities
as program manager.
Inefficient record- keeping - Inspectors spend unnecessary time updating inspec-tion
records. This problem results from management's failure to use support staff for
this task. Additionally, problems with the computerized database contribute to ineffi-ciencies
as inspectors record inspection information on two databases, a card file, and
a case file. ARRA management recently began addressing the former problem by shift-ing
more record- keeping. tasks to existing support staff.
Time wasted on registration - Inspectors unnecessarily spend nearly 20 percent of
their time registering x- ray machines. Rather than requiring x- ray machine owners to
be responsible for providing and updating all the necessary information to register
their machines, inspectors do much of this clerical work. Inspectors personally gather
registration information during inspections and update registration forms between
inspections when registrants provide new or updated information. These processes
could better be handled between the x- ray machine owners and ARRA's support staff,
freeing inspector time for their primary duties. ARRA management cited staff errors,
incorrect registration reporting by x- ray machine owners, and data entry performed
by inspectors rather than support staff as reasons for the significant amount of time
spent on registration.
Time spent on fee collection - Administrative activities include time spent by x- ray
inspectors on annual fee collection from registrants. Interviews with inspectors sug-gest
that support staff can perform most fee collections activities, including updating
change of address information to ensure accurate billings.
In order to shift additional administrative activities to support staff, management should
assess the adequacy of its current support staff levels. If existing support staff is inad-equate,
ARRA could consider hiring additional permanent staff or temporary support
staff. Both ARRA and one of ARRA's divisions, the Medical Radiologic Technology Board
of Examiners, already hire some temporary staff to assist with fee collection, thus allow-ing
them to handle this task without the addition of permanent support staff.
Management neglects to hold inspections staflaccountable - When staff devote more
time to inspections, inspection rates increase, as shown in Table 2. The ARRA inspector
who spent the most time ( 37 percent) on x- ray inspections performed over 550 x- ray tube
inspections. Nonetheless, management does not hold inspectors accountable for time spent
on inspections, the types of inspections each inspector performs ( inspections of some types
of facilities take longer than others), nor the actual number of inspections accomplished.
In other states such as Louisiana and Minnesota, goals are set for the number of inspec-tions
each inspector must perform. While Arizona's program has set inspection goals in
the past, management has not adequately considered these goals in performance evalua-tions.
Table 2
X- Ray and Mammography Tube Inspections Performed and
Percentage of Time Spent on lnspections Per Inspector,
Fiscal Year 1994(")
Inspector One
Inspector Two
Inspector Three
Inspector Four
(") A fifth inspector was added in July 1994, and a sixth inspector will be added in fiscal year 1995- 96.
The unit also employs a non- ionizing x- ray ( lasers and tanning beds) inspector and shares its pro-gram
manager with the Radioactive Materials units.
Source: Auditor General analysis of ARRA x- ray inspection records and time sheets for fiscal year
1994.
Management also does not hold staff accountable for the quality of inspections. Inter-views
suggest that one inspector continuously makes mistakes during routine inspec-tions,
thus requiring other inspectors to check his work or repeat these inspections. These
mistakes include his failure to note serious machine problems that could result in exces-
sive radiation exposure. While the compliance program manager acknowledges that the
quality of this inspector's work is problematic, performance evaluations have not charac-terized
his work as unacceptable.
Lack of scheduling leads to wasted time - Further compounding productivity prob-lems,
unannounced or unscheduled inspections contribute to wasted time. Based on our
observations, inspectors often arrive at facilities for unannounced inspections when the
offices are closed or extremely busy, forcing inspectors to wait or return at more conve-nient
times. In these instances, we documented much time wasted. Also, the lack of basic
information in ARRA's files, such as a facility's hours of operation, partially contributes
to this problem.
ARRA's Director indicated that an interagency agreement between the Industrial Com-mission
( ICA) and ARRA prohibits announced inspections.( l) However, interviews with
ICA officials revealed that announced inspections do not violate any such agreement.
Other states such as Louisiana, Minnesota, Wisconsin, Washington, and Maryland per-form
announced inspections. Additionally, our observations suggest ARRA could do the
same without decreasing quality since facility staff are 1) generally unaware of problems
with their machines and 2) often eager to learn about any problems. Hence, announced
inspections should not be any less effective than unannounced inspections.
ARRA Could Perform
Many More Inspections
ARRA's average x- ray inspection rate compares poorly to inspection rates achieved in other
states. If ARRA improved its inspection rate, it could meet its schedule for performing x- ray
machine inspections, as well as the statutorily defined schedule for mammography machine
inspections.
As seen in Table 3 ( see page 12), productivity rates for six of the seven states reporting this
data exceed the average number of inspections performed by ARRA inspectors during
fiscal year 1994. Four states exceed an average staff inspection rate of 450 tubes per year.
While differences exist between states regarding inspection procedures due to a lack of
federal or nationally mandated inspection procedures or standards, these states indicated
they do conduct comprehensive x- ray machine inspections. These inspections not only
cover the quality, safety, and accuracy of the machines themselves, but also encompass
safety procedures for and the protection of workers, the general public, and the environ-
This agreement recognizes ARRA's authority in conducting inspections of facilities that handle radia-tion
in order to protect workers from unnecessary radiation exposure.
ment. All of these states have adopted regulations for x- ray machines that are similar to
the Conference of Radiation Control Program Directors ( CRCPD) suggested state regula-tions
and/ or FDA performance standards for machines. Additionally, a CRCPD official
commented that inspectors in other state programs usually inspect 400 to 500 tubes annu-ally.
ARRA's management states that 600 annual tube inspections should be an achievable
goal for each inspector. Indeed, one ARRA inspectofs productivity rate of 556 inspec-tions
per year achieved at only 37 percent time spent on inspections ( see Table 2, page 10)
suggests that such a goal is attainable. The official from the CRCPD noted that some states
exceed such figures, particularly states with high concentrations of x- ray facilities in large
metropolitan areas. For example, in Wisconsin, a state that, like Arizona, has two- thirds
of its x- ray tubes in one large metropolitan area, inspectors accomplished an average of
886 tube inspections in fiscal year 1994.
If ARRA x- ray inspectors performed as few as 450 annual inspections, we estimate that
the Agency could meet its inspection schedule. ARRA could devote 1.5 FTEs to
mammography machine inspections and still perform the 2,384 state x- ray inspections
required on average each year according to ARRA's current timetable for inspections.(')
Table 3
Average Number of X- Ray and Mammography Tubes
Inspected Per Inspector, Fiscal Year 1994
Wisconsin
Oregon
Louisiana
Washington
North Carolina
Minnesota
Arizona
Tennessee
Source: Auditor General interviews of radiation program officials in other states and analysis of ARRA's
fiscal year 1994 inspection figures.
' Our estimate is based on the addition of two inspectors that are authorized to be added by fiscal year
1997. Also, 1.5 FTEs are necessary for performing the 210 annual tube inspections since mammography
inspections take considerably longer than other x- ray inspections. Additionally, the program has ex-perienced
an annual growth rate of 60 to 70 tubes for the past few years. If this growth continues, x- ray
inspectors would need to perfom more than 450 annual inspections in future years and/ or ARRA
would need additional inspectors.
RECOMMENDATIONS
1. ARRA should shift administrative and registration duties from x- ray inspectors to
management and support staff. Management should consider whether additional sup-port
staff is necessary, and consider the hiring of temporary clerical staff to perform
duties associated with seasonal fee collection.
2. Management should hold inspectors accountable for number and types of inspections
accomplished and/ or time spent performing inspections. Also, management should
establish performance goals as is done in other states.
3. X- ray inspections should be performed on an announced, prescheduled basis.
( This Page Intentionally Left Blank)
FINDING II
RADIOACTIVE MATERIALS ENFORCEMENT
NEEDS IMPROVEMENT
While radioactive materials ( RAM) inspections appear to be timely and adequate, RAM
enforcement actions are slow and inadequate. Our review of agency enforcement revealed
instances where the RAM program took excessive amounts of time to begin and complete
enforcement actions, including instances extending well over a year. Further, we identi-fied
cases that may have merited stronger enforcement action. The Agency's inability to
assess civil penalties and its lenient enforcement philosophy contributes to untimely and
weak enforcement.
Per agreement with the Nuclear Regulatory Commission, ARRA has direct oversight re-sponsibilities,
including licensure, inspection, and enforcement for radioactive materials.
Uses for radioactive materials include soil- and asphalt- testing gauges, industrial and
medical imaging, and research activities. ARRA conducts inspections of radioactive ma-terials
at different intervals based on the user's license and type of radioactive material in
use. Inspections include an examination of the user's policies and procedures, treatment
records, and radiation safety activities. An inspector will also observe personnel using or
administering radioactive material.
Importance of Strong
Enforcement Program
As noted previously, adequate and timely enforcement is important because research has
shown that exposure to sources of radiation can harm the public health and safety. Al-though
it is impossible to predict the amount of radiation exposure necessary to cause
damage, it is critical to reduce the amount of radiation received by the public to reason-ably
achievable low levels. Consequently, ARM efforts to enforce compliance with its
rules and regulations become extremely important. These efforts should ensure that ra-dioactive
materials users do not endanger the public health. The following example illus-trates
the importance of ensuring compliance with ARRA rules.
In November 1989, a Phoenix hospital incorrectly administered a radioactive treat-ment
that destroyed a woman's thyroid gland. As a result, the woman received more
than 1,000 times the intended dose and inadvertently exposed her children to radia-
tion. Following this misadministration, ARRA conducted an investigation and deter-mined
that the technician on duty did not comply with rules that require confirmation
of the prescription and dosage before giving it to the patient. Although ARM as-sessed
a $ 12,000 civil penalty, this woman faces an increased risk for developing can-cer
and must now medically treat her condition for life.
Violation Notification
Is Not Timely
ARM fails to act promptly on radioactive materials violations. Under ARRA's agree-ment
with the NRC, ARRA must abide by NRC regulations that require it to notify licens-ees
of violations within 30 days. However, ARM frequently misses these deadlines.
Additionally, many licensees also respond late to notices of violation. Excessive report
review and lack of procedures for ensuring timely violation notices and responses con-tribute
to delays.
Notification and response correspolsdence are slow - Notices of violation are untimely.
NRC regulations require that Arizona notify licensees of violations within 30 days fol-lowing
an inspection. We conducted a file review of 80 RAM licensee files with viola-tions,
and determined that on average ( excluding four files for abnormally late notices),
ARRA sends notices of violation to licensees in 33 days. While this average does not greatly
exceed the NRC requirement, we also determined that for 37 of the 80 files ( approxi-mately
46 percent), ARRA mailed notices late, effectively delaying prompt resolution of
violations. Additionally, ARRA transmitted several notices extremely late, including 4
mailed from approximately 74 to 380 days later than the 30- day requirement. Late viola-tion
notices can negatively affect the Agency's ability to enforce its regulations as illus-trated
by the following case examples.
A medical facility received ARRA's notice of violation 410 days after an inspection.
Violations resulted from not checking incoming packages for radioactive material leak-age,
and the radiation safety officer's failure to properly oversee the program. As a
result of this late violation notice, the licensee demanded an explanation for the delay.
The licensee also questioned how, if it had committed violations, the public's welfare
could be protected by the Agency's delay in transmitting the results of the inspection.
ARRA eventually apologized for the late violation notice.
A nuclear medicine supplier received a notice of violation 60 days after an inspection.
The licensee had failed to monitor radiation levels in clothing after performing a medical
radiation procedure. In their response, the licensee pointed out that ARRA dated the
notice almost one month before mailing it. The response also noted the unfairness of
giving a licensee less time to respond than ARRA took to transmit the violation.
In addition to informing licensees of violations in an untimely manner, ARRA often re-ceives
late responses to violation notices. ARRA requires a licensee response to ensure
licensees appropriately address violations, explain why the violation occurred, and detail
steps it will take to prevent its recurrence. However, approximately 26 percent of licens-ees
responded later than ARRA's 40- day requirement, further delaying timely resolution
of the violation. On average, ARRA received these late responses 13 days beyond the 40-
day deadline. Additionally, ARRA received several responses over two months late. Ac-cording
to the RAM program manager, licensees may have violations with severe health
and safety ramifications that require a rapid response. For example:
An industrial company responded to a violation notice 98 days following its receipt.
An ARRA inspection found three violations, including the licensee's failure to con-duct
leak tests on radioactive materials and perform physical inventories of its radio-active
materials at least every six months. The licensee had repeated these two viola-tions
from its previous inspection. Even though these violations and their repeat na-ture
indicate potential problems with the licensee's radiation safety program, ARM
made no effort to ensure a timely response, nor did it take action for the untimely
response.
ARRA's 40- day response deadline also appears lenient. NRC guidelines recommend that
licensees respond to a violation notice within 20 to 30 days following its receipt. Addi-tionally,
Table 4 ( see page 18) shows that Kentucky, Maryland, Tennessee, and Oregon
require licensee responses within at least 20 days. ARRA has submitted a proposed rule
changing the 40- day response deadline to 30 days and is currently awaiting Attorney
General approval.
Table 4
Violation Notice and Licensee
Response Time Frames
ARRA
NRC
Strives for 30 days after inspection
Specifies 30 days
CRCPD Recommends 30 days
Oregon Mailed within 20 days after
inspection
Kentucky Attempts to mail within 14 days
after inspection
Tennessee
Maryland
Mailed within 15 days after
inspection
Might send a notice as soon as
4 days after an inspection with a
report to follow
Requires response within 40 days
Recommends 20 to 30 days
Recommends 30 days
Requires response within 20 days
after receiving notice of violation
Requires response within 15
days after receiving notice'of
violation
Requires response within 15
days after receiving notice of
violation
Requires response within 20
days after receiving notice of
violation
Source: Auditor General interviews of radiation program officials in other states and review of NRC
and Conference for Radiation Control Program Directors ( CRCPD) documentation.
Untimely review and lack of procedures lead to delays - Untimely report review im-pairs
ARRA's ability to act quickly upon finding violations. Before mailing a notice of
violation, the inspector must have his work reviewed by at least one co- worker, the pro-gram
manager, and ARRA's Director. While the manager points to delays with inspec-tors,
inspectors commented that management contributes to delays due to indecisiveness
regarding possible actions against licensees. Additionally, the program manager indi-cated
that his workload causes delays as do reports that are routed through the Attorney
General. The Director also indicated that technical issues, which require additional re-
search or laboratory work, frequently delay the completion of violation notices. How-ever,
the agency can and should transmit notices in a timely manner and indicate on
notices where required that additional follow- up may be needed. This would allow ARRA
to remain timely, but ensure all issues are adequately addressed.
Additionally, ARRA should institute procedures to ensure the timely completion and
transmittal of violation notices within 30 days. Currently, ARRA has no procedures gov-erning
the review process and detailing when all levels of review are needed, how much
time each review stage should take, and when Attorney General review is needed. Ac-cording
to the CRCPD, radiation programs should have written procedures for response
to licensee noncompliance.
RAM Enforcement
Is Not Adequate
In addition to untimely notification, ARRA enforcement actions against licensee viola-tions
are virtually nonexistent. Historically, ARRA has at times used civil penalties as its
primary enforcement tool; however, civil penalties are currently unenforceable. As a re-sult,
ARRA took action against only 4 percent of licensees with violations during July 1,
1993, through December 31,1994, even though several merited strong enforcement ac-tion.
Additionally, the Agency has not made use of other available enforcement options.
Civil penalties are currently unenforceable - Historically, ARRA has relied on civil pen-alties
to ensure compliance with its rules and regulations; however, ARRA currently can-not
enforce its civil penalties. A. R. S. 5530- 687 and 30- 688 provide ARRA the authority to
assess civil penalties. Through rule the Agency has set the penalty range from $ 250 to
$ 4,000 per violation. ARRA used civil penalties until November 1993, at which time the
Agency discovered an internal discrepancy within its rules governing the assessment of
civil penalties. As a result, the Attorney General advised ARRA that it should cease as-sessing
civil penalties until the rule discrepancy could be corrected. While we agree that
ARRA acted appropriately in ceasing to assess civil penalties, more than 12 months passed
before it submitted draft rules to the Governor's Regulatory Review Council for review.
At this time, the amended civil penalty rules are in the State's rule approval process.
Until ARRA discovered the rule discrepancy, it had imposed 11 separate civil penalties
between June 1992 and November 1993. However, since that time at least ten licensees
with repeat violations that warranted civil penalties have not been assessed automatic
civil penalties due to the rule discrepancy.
ARRA enforcement is inadequate - In our review of inspections that ARRA performed
during the 18- month period July 1,1993, through December 31,1994, ARRA took enforce-
ment action against only 4 percent ( 3 of 81 cases) of licensees with violations. While ARRA's
inability to use civil penalties partially explains the lack of enforcement actions, it appears
that the Agency often takes little action beyond sending the notice of violation and ob-taining
the licenseers written response. Our review found that several cases deserved
stronger enforcement action, which ARRA did not take. For example:
A recent inspection at a large hospital yielded 8 violations and 13 items of concern.
( Items of concern can lead to violations in the future if not corrected.) ARRA con-ducted
the inspection after the hospital lost a minor radiation source used for medical
purposes. ARRA found multiple violations that directly contributed to the loss of the
radiation source, including not taking inventory of the source after the procedure, and
allowing an untrained doctor to complete the removal of the source from a patient.
The source was never found, and is believed to be buried in a landfill.
The licensee has a history of numerous violations and items of concern. ARRA has
repeatedly found the same items of concern related to radiation- contaminated areas
in laboratories and a pharmacy ( four times), and radioactive trash included with regular
or unmarked trash. These items of concern, which would have been violations if the
level of radioactivity had been higher, indicate carelessness on the part of the licensee
and are important because the contamination can end up in public areas.
The numerous violations and items of concern merit some type of enforcement action.
However, in three inspections that found violations between 1988 and 1994, ARRA
took no action.
Another large hospital has performed four radiation source misadministrations from
1989 through 1993. In 1989, a patient in the hospital received the wrong radioactive
diagnostic medication. In 1991, a patient was mistakenly given the radioactive medi-cation
intended for his hospital roommate. In 1992, a tube containing radioactive ma-terial
exposed a patient and nurse to a small amount of radiation for approximately an
hour. Finally, in 1993, another misadministration of radioactive medicine occurred.
Despite this history of misadministration and numerous violations, including one re-peat
violation found during an inspection in 1993, ARRA has never taken enforcement
action against this licensee.
ARRA seldom uses enforcenrerzt options - ARRA has many enforcement tools at its dis-posal,
but seldom makes use of them. Based on our file review, ARRA assessed civil
penalties against 3 of 15 licensees with repeat violations, but did not take action against
the remaining licensees nor a licensee with a severe violation which involved falsifying
radiation safety records. Additionally, ARRA did not take enforcement action against
any of 21 licensees that provided late responses to notices of violation.
Other than civil penalties, which are currently unavailable, ARRA rarely takes enforce-ment
action. Statute and rule provides a range of enforcement actions that the Agency can
use including license modification, informal hearings, injunctions, radiation source im-poundment,
and license suspension or revocation. However, the program manager indi-cated
that ARRA has modified licenses only four or five times during the Agency's exist-ence.
In addition, ARRA uses informal hearings to communicate the imposition of civil
penalties, rather than an enforcement tool itself to encourage prompt violation resolution
and compliance with rules and regulations. Moreover, the Agency has never used injunc-tions,
radiation source impoundments, license suspensions, and/ or revocations.
Other agencies employ a variety of enforcement tools to ensure compliance with their
rules and regulations. For example, the Arizona Department of Environmental Quality
( ADEQ) uses consent agreements and compliance orders to enforce compliance with its
rules and regulations. Consent agreements offer many benefits, including a court- enforce-able
order which both parties agree to and understand their obligations. Compliance or-ders
differ in that the Agency mandates compliance; however, the licensee retains the
right to appeal. In explaining their preference to use consent and compliance orders, an
ADEQ official indicated that the Agency wants licensees to spend their money to return
to compliance, rather than paying an administrative penalty.
In addition to these enforcement tools, ARRA might also ensure licensees correct identi-fied
violations through follow- up inspections and/ or an accelerated inspection schedule.
The RAM program rarely performs follow- up inspections, although the Conference for
Radiation Control Program Directors recommends that agencies do so. Additionally,
Kentucky, Maryland, and Oregon conduct follow- up inspections and/ or accelerate the
licensee's inspection schedule to ensure licensees return to and remain in compliance.
Lenient Philosophy Contributes
to Weak, Untimely Enforcement
ARRA's untimely and inadequate enforcement of the radioactive materials program re-sults
in part from the Agency's accommodating relationship with the regulated commu-nity.
Instead of mandating licensee compliance with its rules through a strong enforce-ment
attitude, ARRA prefers to work with licensees in an effort to arrive at compliance.
While maintaining good working relationships with licensees is beneficial, it should not
detract from the Agency's primary mission of regulation. The program manager indi-cated
they do not want licensees to suffer monetary setbacks and prefer to use other en-forcement
methods. However, based on our review of inspections performed between
July 1, 1993, through December 31, 1994, the Agency did not take enforcement action
against the majority ( 96 percent) of licensees with inspection violations. Additionally, in
our November 1984 report on the Agency, we commented on its lenient enforcement
philosophy, noting that ARM feared damaged working relationships with licensees if it
pursued strong enforcement action.
This philosophy toward enforcement filters down to some RAM staff. In one of its re-views,
NRC found inspectors inappropriately issuing items of concern instead of viola-
tions because of inspector perceptions that penalties are too severe. Items of concern iden-tify
problems that can lead to violations if not remedied. The following case example
illustrates ARRA's reluctance to take enforcement action.
H A licensee ( a city) repeated a violation ( failure to perform leak tests) from a previous
inspection, thus meriting a mandatory $ 1,250 civil penalty. After receiving and re-viewing
the city's response, ARRA notified it that the response did not provide a basis
for mitigating or waiving the proposed civil penalty. If the city did not appeal this
order within 20 days, the civil penalty would be assessed. No appeal was received.
However, the inspector, who was under the impression that this city faced bankruptcy,
advised it that ARRA might not impose the civil penalty if they disposed of the par-ticular
piece of equipment involved. The licensee sold the equipment almost five months
later and ARRA dropped the mandatory civil penalty.
Despite disposal of the equipment, ARRA violated its own rule in dropping the pen-alty.
While the rule provides for penalty mitigation if the licensee responds in a timely
manner, the rule specifically states that in the case of repeat violations, the penalty
cannot be avoided by compliance. ARRA has submitted a rule change that will allow
the agency to mitigate penalties in the case of repeat violations. This change currently
awaits Attorney General approval.
RECOMMENDATIONS
1. ARRA should send licensees notices of violations within 30 days after inspection.
2. ARRA should complete revisions to the civil penalties rules and ensure their contin-ued
validity.
3. Once civil penalties are again available, ARRA should impose civil penalties as in-tended
by the regulations on repeat violators and on licensees with late responses to
notices of violation.
4. ARM should use other enforcement actions, including consent agreements, compli-ance
orders, and informal hearings. The Agency should also consider performing fol-low-
up inspections and accelerating the inspection schedule for licensees with viola-tions.
OTHER PERTINENT INFORMATION
During the audit, we collected information regarding the status of and alternatives to the
Southwestern Compact, an agreement between California, Arizona, North Dakota, and
South Dakota, for the disposal of low- level radioactive waste generated in each state. The
lack of a Low- Level Radioactive Waste ( LLRW) disposal site threatens the ability of LLRW
generators in the State to continue their work and may eventually affect public health and
safety. To provide for permanent disposal of low- level radioactive waste, Congress en-acted
legislation requiring states to assume this responsibility, either alone or through
interstate compacts. However, the Southwestern Compact, to which Arizona belongs, has
yet to develop its disposal site resulting in current and potential costs to Arizona LLRW
generators. Other alternatives for disposing of LLRW may exist if the proposed disposal
site in California remains undeveloped.
History of Low- Level
Radioactive Waste
Low- level radioactive waste consists of material contaminated by radioactive material
used in medical practice and scientific research, industrial processes, and nuclear power
plants. These contaminated materials include paper, rags, tools, protective clothing, labo-ratory
glassware, gloves, wood, and filters. For example, medical institutions produce
low- level radioactive waste by using radioactive elements to diagnose heart problems
and treat hyperactive thyroids. Universities generate low- level radioactive waste in can-cer
and AIDS research, drug testing, and carbon- 14 dating for archaeological and anthro-pological
studies. Many industries, including nuclear power plants, also produce this
type of waste.
The U. S. Nuclear Regulatory Commission ( NRC) regulates LLRW disposal and classifies
the type of LLRW disposed. Class A wastes, the least dangerous, comprise over 95 per-cent
of the volume of LLRW and will decay to acceptable levels in 100 years or less. Class
C waste, the most dangerous, must have additional physical safeguards to prevent envi-ronmental
or public harm.
In 1980, Congress enacted the Low- Level Radioactive Waste Policy Act that gave each state
the responsibility for managing and disposing its own low- level radioactive waste. The
act also encouraged states to enter multi- state compacts for LLRW disposal. Each com-pact,
upon receiving congressional approval, could limit LLRW disposal to generators
within the compact region, select a disposal site, and develop a disposal facility. Addi-tionally,
until states formed compacts and constructed disposal facilities, they could re-
tain access until December 31,1992, to the only three operating disposal facilities in the
country: Beatty, Nevada; Richland, Washington; and Barnwell, South Carolina.
In July 1988, Arizona joined California in forming the Southwestern Compact. North and
South Dakota joined the compact in 1989. Legislation designates ARRA as the Arizona
agency responsible for performing any administrative and enforcement duties assigned
to the State by the Southwestern Low- Level Radioactive Waste Disposal Compact. The
compact, governed by the Southwestern Low- Level Radioactive Waste Commission, des-ignated
California as the host state for its disposal facility. As a result, California con-tracted
with US Ecology, a private firm, to identify a site and develop a disposal facility.
Upon completing the necessary environmental studies, US Ecology selected a site on fed-eral
land in Ward Valley, approximately 22 miles west of Needles and the Colorado River.
On September 16, 1993, the California Department of Health Services ( CDHS) issued a
license to US Ecology for the construction and operation of a LLRW disposal facility in
Ward Valley.
Current Status of
Southwestern Compact
Although licensed by CDHS, US Ecology has been unable to construct a disposal facility
in Ward Valley. Several factors, including the U. S. Department of Interior's delay in trans-ferring
ownership of the land to California and various legal actions, have prevented US
Ecology from developing the Ward Valley site.
CDHS granted a license to US Ecology pending transfer of the Ward Valley land from the
U. S. Department of Interior, Bureau of Land Management, to California. California must
purchase the land from the U. S. Department of Interior to ensure full control and imme-diate
access should problems arise. However, the Secretary of Interior placed the land
sale on hold and requested a National Academy of Sciences ( NAS) review of issues raised
by the " Wilshire Report," a report prepared by three geologists employed by the U. S.
Geological Survey,(') which details concerns regarding the appropriateness of the Ward
Valley site. The NAS issued its report in May 1995 finding that the issues raised by the
Wilshire Report are not significant and recommending additional monitoring activities
for the site. California now awaits a federal decision on the land sale.
Also, opponents of the disposal facility are pursuing legal action in an attempt to prevent
its development. In a lawsuit filed in the State of California, opponents seek to void the
license granted to US Ecology based on US Ecology's questionable qualifications, CDHS'
failure to conduct proper hearings on the license, and locating a disposal site in an area
The Wilshire Report was written in 1993 by three geologists, Howard Wilshire, Keith Howard, and
David Miller, who acted as individuals rather than in official U. S. geological capacities. The geologists
prepared the report at the request of a California U. S. Senator.
designated as a critical habitat for the desert tortoise. Additionally, the Wilshire Report
was introduced into the lawsuit. The California Superior Court found that virtually all
issues raised by the opponents were without merit, but the Wilshire Report constituted
new evidence, and ordered CDHS to consider the report in the licensing process. Both
parties appealed and a decision is expected in 1995.
Impact and Alternatives
The delay in developing a disposal facility leaves few viable options for generators of
LLRW in Arizona. The most optimistic estimate would have the disposal facility con-structed
and operating by summer 1996; however, many stakeholders agree legal actions
could continue for many months, delaying the opening of a disposal facility until 1998 or
beyond. Since no authorized disposal facility is available, Arizona LLRW generators have
undertaken waste reduction efforts and/ or substituted non- radioactive materials where
feasible in their operations. Generators have also constructed temporary storage facilities
for waste storage until a permanent site becomes available.
While these actions do not offer a permanent solution for the disposal of LLRW, they buy
time for LLRW generators until a disposal site becomes available. However, LLRW gen-erators
have incurred significant costs to construct temporary storage sites and store waste.
For example, the consortium that operates the Palo Verde Nuclear Generating Station
recently completed construction of a $ 4.6 million LLRW temporary storage facility. Addi-tionally,
the University of Arizona will spend approximately $ 630,000 on a LLRW tempo-rary
storage facility, plus an estimated $ 15,000 in annual operational costs. LLRW genera-tors
in Arizona estimate they only have approximately five years of storage space avail-able.
In addition to the costs incurred for temporary storage, some LLRW generators fear a
direct impact on their operations if a disposal site remains unavailable. Research organi-zations
that use radioactive materials, including the University of Arizona, may have to
curtail research activities if there is no place to dispose of the waste. Organizations may
have, to devote some research dollars to finance temporary storage costs. Additionally,
important medical treatments and research may be negatively impacted.
The State can explore various permanent or temporary alternatives to the Ward Valley
disposal site, some with significant drawbacks.
Barnwell, South Carolina disposal facility opening - One alternative involves ship-ping
and disposing of LLRW at the Barnwell, South Carolina disposal facility. The
South Carolina Governor and Legislature recently enacted legislation that opened
Barnwell on July 1,1995, to all states, except North Carolina.(') Additionally, the South-
western Compact Commission issued a blanket approval authorizing generators within
the Southwestern Compact to export LLRW to this facility, if individual shipments
meet the terms of the approval. As part of its legislation, South Carolina will also
begin to explore new compacting arrangements. However, the Barnwell facility could
become a superfund clean- up site, meaning that liability for cleanup could extend to
the disposers of the waste. For this reason, the University of Arizona has not and
stated they will not dispose of their LLRW at Barnwell. Also, in September 1995, a
lawsuit was filed in South Carolina in an effort to reverse the legislation that opened
Barnwell to all states.
Arizona disposal or temporary storage site - Alternatively, Arizona might consider
developing its own disposal site or temporary storage site. However, these options
may be difficult to implement. First, Arizona must go through the same lengthy pro-cess
in siting a disposal facility and performing all the requisite environmental studies
as California. Additionally, Arizona would likely experience similar opposition. Sec-ond,
Arizona would be unable to restrict a disposal or storage facility to only Arizona
generators of LLRW. Such a restriction would violate interstate commerce laws. Ari-zona
generators also do not produce sufficient quantities of LLRW to entice a private
company to operate a disposal or storage facility. Such an operation would require
waste from additional sources outside the State.
Possible legal remedies - Finally, Arizona could seek legal remedies from Califor-nia
for its failure to develop a disposal site by January 1,1993, as legislated and agreed.
Arizona could either seek monetary damages or force California to accept the LLRW
generated in the State. Some stakeholders suggest that California might welcome such
a lawsuit as it might provide the additional impetus needed to counter opposition and
construct the disposal facility. Other stakeholders indicate that California is doing all
it can to build the facility and a lawsuit would be counterproductive and possibly
damage relations between the states.
South Carolina believes that North Carolina has not kept its agreement with the Southeast Compact to
construct an LLRW disposal facility. As a result, the South Carolina legislation denies access to Barnwell
to North Carolina generators of LLRW.
SUNSET FACTORS
In accordance with A. R. S. 541- 2954, the Legislature should consider the following 12 fac-tors
in determining whether the Arizona Radiation Regulatory Agency should be contin-ued
or terminated.
1. The objective and purpose in establishing the Agency.
In 1980, the Arizona Radiation Regulatory Agency ( ARRA) was established, replac-ing
its predecessor agency, the Arizona Atomic Energy Commission. The intent in
establishing ARRA is to reduce the risks to the public resulting from exposure to
radiation. Laws 1980, Ch. 206 51 state:
" It is declared to be the policy of this state to protect the public health and
safety by regulating ' the use and sources of radiation to provide far: ( 1) use of
methods and procedures relating to radiation which are demonstrated to be
safe; and ( 2) maintaining exposure to sources of radiation in amounts as low
as is reasonably achievable by means of good radiation protection planning,
practice and enfarcement. "
According to A. R. S. 530- 654. B ( 1) and ( 4), ARRA shall regulate the use, storage and
disposal of sources of radiation; and assume primary responsibility for and provide
necessary technical assistance to handle any incidents, accidents, and emergencies
involving radiation or sources of radiation occurring within this State.
2. The effectiveness with which the Agency has met its objectives and purpose
and the efficiency with which it has operated.
The Agency has generally met its objectives and purpose. To comply with its objec-tives,
the Agency licenses radioactive materials and registers all types of radiation
machines in the State. The Agency also inspects licensees and registrants. However,
we found that the Agency can do more to further safeguard the public health and
safety by:
Meeting inspection schedules for x- ray and mammography machines. The
Agency currently faces almost a 30 percent backlog in inspections for x- ray
tubes and a 77 percent inspection backlog for mammography tubes. ( See Find-ing
I, pages 5 through 13.)
Taking timely and adequate enforcement actions against radioactive materials
violations. ( See Finding 11, pages 15 through 22.)
ARRA has effectively responded to radiation- related emergencies and incidents
within the State. During the course of our audit, ARRA immediately and effectively
responded to a radiation incident in Tucson. Additionally, ARRA has performed
effectively during federal test exercises that evaluate the State's ability to respond to
radiation emissions from the Palo Verde Nuclear Generating Station.
3. The extent to which the Agency has operated within the public interest.
The Agency has generally operated within the public interest through its inspection,
emergency response, and environmental surveillance ( laboratory) activities. In ad-dition
to these activities, the Agency maintains a radon program that provides pub-lic
information to organizations and individuals, handles approximately 700 radon-related
inquiries per year, and provides ongoing assessment of potential radon haz-ards
in Arizona. However, the public interest could be better served if ARRA quickly
addressed its backlog of x- ray and mammography machine inspections and stayed
current with its inspection schedule. ( See Finding I, pages 5 through 13.)
4. The extent to which rules and regulations promulgated by the Agency are
consistent with the legislative mandate.
Rules and regulations promulgated by the Agency appear consistent with the legis-lative
mandate. Additionally, several articles are in various stages of development,
including an article to correct the rule discrepancy associated with the Agency's
ability to assess civil penalties. Despite these efforts, the Nuclear Regulatory Com-mission
( NRC) has cited ARRA for its failure to maintain regulations consistent with
NRC federal regulations as required by its agreement. The NRC noted this problem
in its June 1992 and March 1995 review of Arizona's radiation control program. ARRA
cites the State's lengthy rule- making process and insufficient staff to promulgate
rules as reasons for not maintaining rules consistent with NRC federal regulations.
5. The extent to which the Agency has encouraged input from the public before
promulgating its rules and regulations and the extent to which its has informed
the public as to its actions and their expected impact on the public.
The Agency appears to comply with open meeting law requirements regarding pub-lic
rules and regulation hearings. The Agency posts its meeting notices in a timely
manner and in accordance with the statement filed with the Secretary of State. Ac-cording
to the Agency Director, the Agency will revive a newsletter to inform the
public of proposed rulemaking actions.
6. The extent to which the Agency has been able to investigate and resolve com-plaints
that are within its jurisdiction.
Based on a limited review of consumer complaints received by the Agency, it ap-pears
that the Agency adequately investigates and resolves complaints. The Agency
reported receiving 14 complaints regarding its non- ionizing radiation program dur-ing
the past year and very few in its other program areas.
7. The extent to which the Attorney General or any other applicable agency of
state government has the authority to prosecute actions under enabling legis-lation.
According to A. R. S. 530- 685, the Attorney General has authority to make application
to the appropriate court for an order prohibiting any act that violates ARRA's stat-utes,
rules, or regulations. Additionally, the Agency has specific statutory authority
to assess civil penalties, impound radiation sources, and modify, suspend, or revoke
licenses. A. R. S. 530- 687. A requires the Attorney General to bring actions for collect-ing
civil penalties.
8. The extent to which the Agency has addressed deficiencies in the enabling
statutes which prevent it from fulfilling its statutory mandate.
Currently, the Agency perceives the inability of the State to order a person to clean
up an area that he contaminated, and that endangers the public health, as a statutory
deficiency. The Council of State Governments Suggested State Legislation for radia-tion
control programs recommends that states possess this authority. However, the
Governor can only order the State to remedy a contaminated area, not the person
who caused the public health problem. The Agency has proposed legislation ad-dressing
this concern in the past, but legislation has not been enacted.
9. The extent to which changes are necessary in the laws of the Agency to ad-equately
comply with the factors listed in the subsection.
Other then the inability of the State to order a person to clean up an area that he
contaminated, we identified no additional changes that are necessary in the laws of
the Agency to comply with the statutory requirement of protecting public health
and safety.
10. The extent to which the termination of the Agency would significantly harm
the public health, safety, and welfare.
Termination of the Agency could significantly harm the public health, safety, and
welfare. Radiation exposure poses considerable health risks, including cancer, ge-netically
determined ill- health, and developmental abnormalities. ARRA's regula-tion
programs including inspection, licensing and registration, emergency response,
and environmental surveillance serve to mitigate risks associated with radiation,
both man- made and naturally occurring.
11. The extent to which the level of regulation exercised by the Agency is appro-priate
and whether less or more stringent levels of regulation would be appro-priate.
Our review found that ARRA is not exercising appropriate regulation over licensees
and registrants. As discussed in Finding I ( pages 5 through 13) and Finding I1 ( pages
15 through 22), ARRA faces a large inspection backlog for registered x- ray and
mammography machines; and rarely takes enforcement action against licensees
with violations.
12. The extent to which the Agency has used private contractors in the perfor-mance
of its duties and how effective use of contractors could be accom-plished.
The Agency does not use private contractors in the performance of its primary du-ties.
Even though several states employ private contractors to perform inspections of
licensees and registrants, the Agency believes that privatizing the inspection func-tion
would not reduce the costs to the State for administering the program and would
likely lead to higher costs for the regulated community. According to radiation offi-cials
in Colorado, which has privatized inspections, privatization has proven cost-lier
for registrants, requires significant staff expertise to review reports and monitor
contractors, and has been difficult to implement. Colorado also reports that
privatization requires a sophisticated tracking system to ensure timely inspections
and information flow between the state, contractors, and registrants. Other states
and the Conference for Radiation Control Program Directors confirm this informa-tion.
The Agency does contract out for the analysis of its employees' film badges, which
are used to assess the radiation exposure of individuals who work near radiation.
The Agency also uses contractors for instrument calibration, specialized employee
training, and radiation source cleanup and disposal.
INTRODUCTION AND BACKGROUND
The Radiation Regulatory Hearing Board was established in 1980 to serve as a vehicle for
appeal by any person adversely affected by an order of the ARRA. The Board consists of
five members appointed by the Governor to five year- terms. The Board last met on Janu-ary
27,1993, and March 25,1993, to decide appeals of ARRA orders. The Board has not
met during fiscal years 1993- 94 and 1994- 95.
Given the infrequent nature of Board meetings and activities, our review was limited to a
review and preparation of sunset factors for the Board.
( This Page Intentionally Left Blank)
SUNSET FACTORS
In accordance with A. R. S. 541- 2954, the Legislature should consider the following 12 fac-tors
in determining whether the Radiation Regulatory Hearing Board should be contin-ued
or terminated.
1. The objective and purpose in establishing the Board.
According to A. R. S. 530- 653 the Radiation Regulatory Board was established in 1980
as part of the act that also established the Arizona Radiation Regulatory Agency.
The Hearing Board provides a vehicle for appeal by any person adversely affected
by an order of the ARRA or its director. The Board may also review and make rec-ommendations
to ARRA and the Legislature regarding rules and regulations pro-mulgated
by ARRA, as stated in A. R. S. 530- 655. D.
The Board, which consists of five members appointed by the Governor, last met on
January 27,1993, and March 25,1993, to decide appeals of ARRA orders. The Board
has not met during fiscal years 1993- 94 and 1994- 95. This coincides with ARRA's
inability to assess civil penalties. Consequently, there has been no appeal of a civil
penalty, which would require the Board to meet.
2. The effectiveness with which the Board has met its objectives and purpose
and the efficiency with which it has operated.
According to the Board, it has reviewed appeals in a timely manner, and in the
majority of cases, affirmed ARRA's decision. In some cases, the Board has modified
the amount of civil penalty assessed; however, the Board has never revoked an or-der
of the agency. Additionally, no Hearing Board decisions have been appealed to
the Superior Court. Finally, the Board reviews and comments on draft rules and
regulations proposed by the Agency.
Based on our review of Board decisions since 1990, we found that it had reduced
three civil penalties ordered by ARRA. In other instances, the Board upheld the or-der
of ARRA. Also, the Board rendered its decisions within approximately four to
eight months following appeal.
3. The extent to which the Board has operated within the public interest.
The Board believes it acts in the public interest by providing an appellate review of
ARRA enforcement actions. The Board's independence and action in the public in-terest
are demonstrated in those cases where the Board has reduced a proposed civil
penalty.
4. The extent to which rules and regulations promulgated by the Board are con-sistent
with the legislative mandate.
Since the Board only performs an appellate function, it does not promulgate rules
and regulations.
5. The extent to which the Board has encouraged input from the public before
promulgating its rules and regulations and the extent to which its has informed
the public as to its actions and their expected impact on the public.
The Board does not promulgate it. own rules and regulations.
6. The extent to which the Board has been able to investigate and resolve com-plaints
that are within its jurisdiction.
The Board does not receive complaints from consumers.
7. The extent to which the Attorney General or any other applicable agency of
state government has the authority to prosecute actions under enabling legis-lation.
The Board has no enforcement authority.
8. The extent to which the Board has addressed deficiencies in the enabling
statutes which prevent it from fulfilling its statutory mandate.
The Board has not proposed any changes to its enabling statutes.
9. The extent to which changes are necessary in the laws of the Board to ad-equately
comply with the factors listed in the subsection.
We did not identify any changes that are needed in the Board's enabling legislation
to adequately comply with the Sunset Factors.
10. The extent to which the termination of the Board would significantly harm the
public health, safety, and welfare.
Terminating the Board would not harm the public health, safety, or welfare. How-ever,
the Board appears to provide a check and balance on the actions of the agency
and provides a timely, less expensive alternative to court actions.
11. The extent to which the level of regulation exercised by the Board is appropri-ate
and whether less or more stringent levels of regulation would be appropri-ate.
This factor does not apply because the Board has no regulatory functions of its own.
12. The extent to which the Board has used private contractors in the performance
of its duties and how effective use of contractors could be accomplished.
The Board uses private hearing officers to conduct hearings on appeals of ARM
actions. The full Board then acts on the recommendations of the hearing officer.
Contracts for hearing officers are handled through the Department of Administra-tion.
According to the Board, this mechanism has proven to be effective.
( This Page Intentionally Left Blank)
Agency Response
Arizona Radiation Regulatory Agency
@ I~@ NA RADIATION REGULATORY AGENCY
4814 South 40 Street Phoenix, Arizona 85040
Fife Symlnoton
Governor
Aubrey V. Godwin
( 602) 255- 4845
FAX ( 602) 437- 0705
October 19, 1995
Douglas R. Norton
Auditor General
Office of the Auditor General
2910 North 44th Street, Suite 410
Phoenix, AZ 85018
Dear Mr. Norton;
Thank you for the opportunity to respond to the Draft Report of the performance audit of the Arizona
Radiation Regulatory Agency. We appreciate the professionalism exhibited by the audit team during the
review process. They should be commended for their grasp of the many technical issues facing the Agency.
Due to the highly technical nature of this program, I request that the enclosed Conference of Radiation
Control Program Directors' " Review of Radiation Control in Arizonan be attached to this report. Even though
referenced in our response, I am not requesting that the U. S. Nuclear Regulatory Commission review and
evaluation, dated June 7, 1995, be included with the report but to be available on request.
We have some comments which should be associated with and attached to the report to give the reader a
better perspective of the Agency operations and perhaps clarify the information in the report. These comments
are as follows;
1. We believe that it would be clearer to the readers if the report did not intermingle the situation at the
time of audit with the current status without specifying which period is applicable. For example on
page 2 of the report, the FTEs listed for X- ray, Mammography, and Non- ionizing Radiation are
7.5. Actually, during the period audited by this report, the Agency was authorized only 6.5 FTEs for
x- ray, mammography, and non- ionizing program. The 7.5 became effective on July 1,1995, after the
audit portion was closed.
2. The data presented in this paragraph were calculated for a period prior to the end of the audit portion
of the review. Although close to the end of the review, had the data been corrected for the end of the
review period, it would have shown 76.0% overdue by one year and 34.5 % overdue by two or more
years. As of October 1, 1995 the percentages are 55.3% and 34.1% respectively. We believe that
these changes in percentage overdue support the actions identified by Agency management, and the
Conference of Radiation Control Program Directors. Some of these are the same as identified by the
Auditor General while others are more technical.
3. Figure 1. on page 8, does not indicate that the Paid Leave includes 5 % for legal holidays and 6% for
coffee break time. Further, all state employees are authorized 4% of the year as annual leave. Many
time studies leave out coffee break time.
4. The last paragraph on page 8 does not recognize that the employee involved was the " lead inspectorn
Douglas R. Norton
October 19, 1995
Page 2
and had some supervisor/ managerial responsibility. It is within management's authority to assign
management activities to subordinates, otherwise, since a given manager is responsible for all
activities under their control, he could not ask any subordinate to perform any activity. Management
recognized the difficulties associated with this arrangement and began discontinuing this practice prior
to the Auditor General's review. The use of " lead inspectors" was necessitated by the reduction in
managerial staff in the Agency and the subsequent reorganizations.
The Auditor General's Report appears to have a total lack of recognition that even though staffing is
limited, the total administrative workload for approximately 8,000 x- ray tubes remains the same, and
must be performed by the few available staff. In fact in 1985 when the last Auditor General's Review
was conducted, the Agency had 4 x- ray inspectors for 5,632 tubes. Since 1985, the number of x- ray
tubes has increased to 8,125 or a 44% increase by 1995. During the same period the inspection
staffing increased 20 % . The additional inspector was for the Mammography program funded by the
U. S. Department of Health and Human Services. The Agency was behind in its x- ray inspection
program in 1985 and has not received the resources to catch up. The Conference of Radiation Control
Program Directors in their criteria for x- ray programs indicate that smaller programs have an
increased administrative workload per inspector. In their 1995 review, page 5, clearly recognized that
smaller staffs have to spend more time per person on administrative duties than large staffs by quoting
the range of FTE/ 1,000 x- ray tubes. The 1.4 FTE/ 1,000 x- ray tubes is for the large staff and the 2.1
FTE11, OOO x- ray tubes is for the small staff. Further, for FY 1989 to FY 1993 the staff available to
the Agency was reduced each year, which limited trained support and technical staff within the
Agency.
5. The last sentence of this paragraph ( on page 9) appears to be based on information supported by the
discussion in the next paragraph. Unfortunately, the reviewers did not recognize that the power line
siting actions are a part of the non- ionizing radiation management duties nor that the Low Level
Radioactive Waste activities are a part of the radioactive material management duties. These are the
primary duties of this individual and he is not in a position to pick and chose about performing them.
Agency management has recognized that this particular manager was over tasked and is taking steps
to correct the situation.
6. The third full paragraph on page 9 indicates that technical staff time is wasted on registration. The
paragraph does not recognize that the registration by non- technical staff resulted in significant errors
in the records and has increased the time required by the technical staff to correct the errors. The
Agency has moved data in- putting to the administrative staff.
7. The last paragraph on page 9 is quite correct when the Auditor General recommended that we use
temporary help for processing the fees. As a matter of fact, both the Agency and the Medical
Radiological Technology Board of Examiners used temporary staffing January 1995 which is not
mentioned in the report.
8. On the top of page 10, omitted in these statements in the first paragraph is, currently management
does hold the inspectors accountable for the quantity and quality of work. Further, during the period
reviewed, initial steps were being taken by the current management to identify the problem and
establish performance goals. The ability to receive a pay raise is directly tied to the performance of
Douglas R. Norton
October 19, 1995
Page 3
each individual inspector.
We have suggested that calendar 1994 is a better indicator than FY 1994 data for several reasons. A.
Several of the inspectors had less than one year experience as an independent inspector during this
period. Indeed, two had not completed their training to be independent inspectors. B. One inspector
was phasing into non- ionizing radiation, and while not included in the table, did influence the
activities of the x- ray program.
9. The last paragraph on page 10 indicates that one employee is not being held accountable for his
actions and that his performance evaluations do not reflect the worker performance. Contrary to the
statements in the report, the individual's performance was graded below standard in 1995 and 1992
for several areas of work. Management was careful to document the quality of work and base the
performance evaluations on the documentation rather than contemporaries opinions in order to
preserve the individual's civil and employment rights. See also response 8. above.
10. Notwithstanding the comments in the first full paragraph on page 11, A. R. S. 623- 408 C. clearly states
that notice of an intended inspection shall not be given to an employer prior to the time of actual entry
upon the workplace. While it is true the interagency agreement does not address this point
specifically, it is clear that the Director of the Division of Occupational Safety and Health did not
grant an exemption to this portion of the statue. Further, in other states, the U. S. Occupational Safety
and Health has determined that occupational inspections should be unannounced. The basis of the
selection of the states listed is not clear to this point, for example, does each state have an
occupational safety and health program approved by the U. S. Department of Labor? Is the Radiation
Control Program a portion of that agreement?
The experience of the director in another state radiation program which performed both scheduled and
unannounced inspections, is that for the inspectors time it makes no difference which is used. This
is due to;
A. The inspector must take time to call and set inspection appointments, attempting to get
them in close proximity with each other.
B. For a significant number of the appointments, the facility is not ready for the inspector
due to patient considerations.
C. When scheduling appointments, some extra time must be allowed so that when a
problem arises, the inspector will not be late for the next appointment.
D. When appointments are made, if a problem occurs, the inspector is pushed to ignore
or the rush through the problem rather than taking the time to resolve the problem
correctly.
E. On occasion a facility has refused to set an appointment for an inspection.
11. The Auditor General's Report glosses over the effects of the differences between states in their
Douglas R. Norton
October 19, 1995
Page 4
compliance programs. The differences are very significant in the number of inspections per inspector.
In assessing the appropriateness of the states selected in Table 3, the Auditor General's Report does
not indicate how many support staff these states legislatures have authorized for these programs; the
ratio of each type of x- ray tube usage to the total number of x- ray tubes; the computer support
available; any independent review of these states inspection programs to assure that the regulations
are being followed. Without this and similar data it is impossible to conclude that the information is
comparable with Arizona. In fact, 30% of the states contacted by the Auditor General apparently
consider inspection performed per year per inspector to be such a poor basis for judging performance
that they do not even track the number of inspections performed by each inspector, Maryland,
Colorado, and Oklahoma.
12. The Nuclear Regulatory Commission review did not indicate any problems with slow enforcement.
Specifically, 2. and 4. of Enclosure 2 and 21., 22., and 23. of Enclosure 3 of that review do not
indicate any problems with our enforcement actions. Further, the Nuclear Regulatory Commission
review did not find a problem with our follow up on non- compliances.
Thank you again for this opportunity to respond.
S& inc;&< e! re, l,, yY' / A1
Aubrey V! ~ odwin
Director
ENC
Review of
Radiation Control in Arizona
by the
Conference of Radiation Control
Program Directors, Inc.
August 1995
Prepared and published by the
Office of the Executive Director
CRCPD, 205 Capital Avenue
Frankfort, Kentucky 4060 1
Phone 5021227- 4543
Table of Contents
Page
Executivesummary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Bases of Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Detailed Findings and Recommendations
X- Ray and Radioactive Materials Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Non- Ionizing Radiation Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Environmental Monitoring Program and Laboratories . . . . . . . . . . . . . . . . . . . . 13
Emergency Response Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Members of the CRCPD Review Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Persons Interviewed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Executive Summary
The Conference of Radiation Control Program Directors, Inc., ( CRCPD) is a professional
association for governmental radiation control program personnel in the United States and Canada
The CRCPD promotes adequate, uniform control of radiation hazards. As one of its services, the
CRCPD will review the radiation control program of a state and recommend improvements.
The Director of the Arizona Radiation Regulatory Agency ( ARRA) requested, in May 1995, a
comprehensive review of radiation control in Arizona. A team of six volunteers from state and
federal radiation control programs, and one CRCPD staff person, was promptly enlisted to carry
out this review. The team reviewed the statutory basis for the program, the forms and procedures
used, information retained in the files, and interviewed staff and legislators June 25- 30.
The review of radiation control in Arizona found the program to be quite well developed by
professional standards, active, and well equipped except as noted in the following findings.
The empowering legislation is comprehensive of all types of radiation, and lacks only provisions
for the emergency impoundment of sources and for the certification of radioassay laboratories.
The regulations for radiation control conform to the requirements for the federal programs with
which Arizona is involved and to the Suggested State Regulations. Unfortunately, Arizona's
process for regulation adoption, even for improvement of a radiation source registration form, is
entirely too cumbersome to maintain compliance with the ever- changing federal requirements and
to be responsive to new information on radiation hazards. Also, the few revisions should be made
to meet the requirements for CRCPD recognition of the Arizona licensing of naturally occurring
and accelerator produced radioactive materials. This is a national program that enhances the
uniform and adequate control of these materials, and it provides for reciprocal recognition of
licenses at considerable cost savings to both the licensee and the regulatory agencies.
The management plan for the ARRA, with a scope of five years, should be updated annually to
defme goals, utilize resources, assure coordination among the components of government that
have responsibility for radiation control, and stem the continuing loss of qualified staff.
More numerous state position categories and pay grades are sorely needed in the ARRA. The
ARRA inspectors and clerical staff need relief from the burden of fee collection. They must
instead give more attention to legally sound documentation of their radiation control activities.
Priority should be given to enhancing inspection, guidance to users, and enforcement of
regulations on medical x- ray because this is by far the largest source of exposure to man- made
radiation and for which the largest reduction of unnecessary exposure can be accomplished.
Detailed recommendations for actions by the legislative and executive branches of government,
and the radiation control program of Arizona government are provided in this report.
Introduction
The Conference of Radiation Control Program Directors, Inc., ( CRCPD) is a professional
association for the staff of govemment radiation control programs throughout North America.
The objective of the CRCPD is to promote adequate, uniform control of radiation hazards.
One of the services of the CRCPD is, upon request by a state, to review the radiation liaz& ds and
the radiation control program in that state, and to recommend improvements in regulation and
control. Following such a request, the CRCPD Executive Director assembles a review team that
consists of technical staff of relevant federal agencies and their regional offices, a director of the
radiation control program in another state, and staff of the CRCPD Office of Executive Director.
This team interviews members of the radiation control program and other persons involved with
the use or the control of radiation. The on- site review concludes with a presentation to state
govemment officials of a summary of the significant findings and recommendations. The review
team then prepares a detailed written report which is submitted to the director of the radiation
control program.
The Director of the Arizona Radiation Regulatory Agency, in May 1995, requested a
comprehensive review of the radiological health program in Arizona On- site interviews were
conducted during the week of June 25- 30, 1995.
The aspects of radiation control that were reviewed were x- ray, radioactive materials, low- level
radioactive waste, indoor radon, environmental surveillance, nuclear safety, emergency response,
contaminated sites, non- ionizing radiation, and administration of the radiation c. o. n trol program.
The recommendations were based on information in the following documents:
Council of State Governments, 1983, Suggested State Legislation, Radiation Control Act.
Conference of Radiation Control Program Directors, 1991, Suggested State Regulations for Control
of Radiation, 8th edition
Conference of Radiation Control Program Directors, 1981, Criteria for Adequate Radiation Control
Program, X- Ray
Conference of Radiation Control Program Directors, 1982, Criteria for Adequate Radiation Control
Program, Radioactive Materials
Conference of Radiation Control Program Directors, 1985, Criteria for Adequate Radiation Control
Program, Nonionizing
Conference of Radiation Control Program Directors, 1986, Criteria for Adequate Radiation Control
Programs, Environmental Monitoring and Surveillance
Conference of Radiation Control Program Directors, 1990, Criteria for Adequate Radiation Control
Programs, Radon
CRCPD Recognition of Licensing States for the Regularion and Control of NARM, 1994
Arizona X- Ray and Radioactive Materials
Program Review
Narrative Report
An assessment of the population radiation exposure, made by the National Council on . Radiation
Protection and Measurements ( NCRP 93) in 1987, found- that uses of radiation in the he& ng arts
represent approximately 83% of the total man- made exposure to the U. S. population. In contrast,
occupational exposures were less than 2% and exposure to the entire nuclear fuel cycle was less
than 0.5% of the total man- made exposure. Not only is diagnostic x- ray by far the single largest
source of exposure to man- made radiation, it is also the source for which the biggest dose
reduction gains in man- made exposures can occur without having a negative impact on the
benefits for the public.
The review of the x- ray program revealed that the Arizona statutes ( especially Title 30 Chapter 4,
Section 651, et seq. last amended in several ways in 1992) provide for a program that is
consistent with that suggested by the Criteria for an Adequate Radiation Control Program.
Therefore the limitations of the program are the limitations of resources and perhaps design rather
than statutory. The regulations were last updated in 1986; further modifications to update these
regulations are difficult because of increasingly arduous procedures established by the legislature
( 1995 changes to the Chapter 251 have further complicated the process). The current process
requires not only the typical public process of rules promulgation, but there are now two review
groups involved as well, one at the Governor's level ( the Governor's Review Council) and one at
the legislative level ( the Administrative Rules Oversight Committee). The result is that even more
personnel resources than would be normal must be applied to this aspect of managing the
radiation control program. Periodic adjustments in the regulations are necessary for several
reasons, some will be the result of needs internal to the radiation control program but perhaps
most are external forces that must be accommodated, e. g. new sources of radiation, new
procedures or changes required by federal law.
A note of caution, ( an item not discussed during the exit interview) - it appears
that some program vulnerability may result from potential uneven regulatory
practices. The 1995 changes in the administrative rules section of the Arizona
statutes suggests a reduced burden of proof necessary for a complainant to receive
a financial award against the Agency. The complaint could be a simple one
suggesting that the agency's regulatory requirements were more strictly enforced on
his operations than they were on another facility. Since the Agency's " practice or
substantive policy statement" ( sec. 41- 1030 and 41- 1033) are held in the same light
as formal rules, it appears that all actions of the Agency are made much easier to
contest and subject to feelcost recovery from the Agency's operating funds.
The opinions formed about the x- ray and radioactive materials programs as recorded here are the
result of a review of the statutory basis for the program; a review of the forms and procedures
used in registration/ licensing and inspections; information retained in the files; and interviews with
several of the staff and management. No attempt was made to evaluate the quality of the
inspections by accompanying the inspectors during an actual inspection, nor was any attempt
made to evaluate the inter- inspector consistency of inspection except through reviews of the data
in the inspection reports and compliance letters currently being issued.
Findings and Recommendations
X- ray and Certification Program
The Arizona x- ray program has the normal inspection and compliance functions. The Agency
also has the Medical Radiologic Technology Board of Examiners ( MRTBE), who manage the
certification of ionizing radiation machine operators other than dental hygienists. The MRTBE is
currently staffed by two persons, a professional FTE and a clerical assistant, The MRTBE staff is
able to maintain ( with difficulty) pace with the applications for certification and renewals of the
currently 3,500 registered x- ray technologists in the State. Clearly this is possible because of the
strategy of utilizing the examinations of the American Registry of Radiologic Technologists
( ARRT). Although authorized to develop other tests, the MRTBE believes that this is the fairest
since the ARRT has had a psychometrician validate all of the questions used as appropriate for
the profession. Although dated, the Agency has copies of past examinations which could be used
if the ARRT examination were unavailable. The prime workload of the MRTBE staff appears to
be routine review of applications and assuring the renewal of certificates. Much of the work is
devoted to responding to routine telephone calls from technologists who have not completed
applications within the required time frames. A significant portion of the professional FTE is
devoted to receiving and investigating complaints about illegal or unethical conduct. Because of
the workload, there is little room for difficulties in the program. Should the staffing become
compromised, the impact on technologists and on public health and safety would be appreciable
because of not only expiring certificates but the potential for uncertified practitioners.
The X- ray inspection and compliance group is currently staffed at 4 FTE's and is responsible for
8,198 tubes in 3,574 facilities. An additional FTE is dedicated to mammography inspections
under FDA contract. The program manager must split his attention between the x- ray program
and the radioactive materials program.
Radioactive Materials Program
Arizona regulates certain of the radioactive materials covered by the federal Atomic Energy Act
under an agreement with the Nuclear Regulatory Commission ( NRC). Because the NRC
completed its last program review of Arizona in March 1995, the CRCPD review team did not
focus on the licensing and inspection activities that are evaluated during the NRC evaluation.
The periodic reviews of the materials program by the NRC have been effective in maintaining the
adequacy of the radioactive materials program. However, until this CRCPD review, there has
been no outside, systematic, peer review of the x- ray program. " Sunset review" of the overall
program was recently completed; however, no information about the findings were available. A
previous sunset review occurred in 1985.
Recommendation # 1
CRITERIA: A radiation control program should have adequately trained staff to provide the
necessary professional service for a comprehensive program in radiation protection. The x- ray
program should have between 1.4 and 2.1 professionaVtechnical FTE per 1,000 tubes.
FINDINGS: Recent staffing restrictions have made a poor staffing situation in the x- ray
inspection and compliance program even worse. Inspection reports do not document that all
appropriate sections of Arizona's regulations are being met, nor would they be able to withstand a
legal challenge.
In addition to the problems cause by under- staffing, the x- ray program has lost a management
position. The technical demands, diversity and differences between the x- ray program and the
radioactive materials program is such that one person has difficulty overseeing both programs.
While the existing staff are reasonably well trained, they seem overwhelmed with the workload.
Pressures to increase the inspection rates to levels of 500 tubes per year for each person are not
realistic for the inspection frequencies and the mix of x- ray facilities found in Arizona
The inspection routine has been modified, as a result of severe under- staffing to the following
frequency ( CRCPD recommendations provided for comparison):
Current CRCPD
Arizona Frequency Recommended Frequency
Hospitals 2 years Hospitals 1 year
Radiology clinics 2 years Radiology clinics 1 year
Other medical 3 years Other medical 2 years
Dental 4 years Dental (! 4 visited) 5 years
Industrial 4 years Industrial 2- 4 years
Recommendation # 1 II
Arizona should have 14 professionaVtechnicaI FTE and 3 clerical FTE to support a
comprehensive x- ray inspection and compliance program with facility inspection
frequencies approaching those suggested by the CRCPD. At least one additional
FTE supervisor/ manager is required.
COMMENT: The current staffing levels prevent the Agency staff from providing facilities with
the kind of assistance that would improve the recognized benefits of medical x- ray procedures.
As one example, it appears that no attention is being paid to the objective evaluation of film
processing techniques even though the procedures have been readily available to the staff for
several years though the CRCPD Nationwide Evaluation of X- ray Trends ( NEXT) program.
The CRCPD frequencies cannot be met by Arizona without significant additional resources. The
staffing levels recommended by the CRCPD ( note the special approach to dental facility
inspections) to achieve the recommended frequency would require approximately 17 FTE
( including 3 clerical FTE). In addition to providing the recommended inspection frequency, this
staffing level would also afford the opportunity for the inspectors to provide the facilities with
help in improving the quality of the radiological practices in many of the same ways currently
required by the Mammography Quality Standards Act.
Adequate clerical support would free up the professional/ technical staff to concentrate on the
health and safety issues rather than registration issues.
Recommendation # 2
CRITERIA: The day- to- day operations of the x- ray and the radioactive materials programs
should each be guided by their overall written management plans of the respective programs.
The plans should be based on data showing the extent to which workers and patients are exposed
to sources of radiation. The long and short term objectives should be established with specific
targets for priority and accomplishment. The plan should include periodic evaluation of program
effectiveness and a method to demonstrate the changes in exposure to the workers and public that
have occurred.
FINDINGS: Cunently the program operates on a basic management plan that is known by the
individuals involved but appears to be limited to inspection goals ( i. e. numbers of inspections
completed). The plan is only short term, that is, it is based on recent changes in regulations and
the need to inspect facilities against new rules. Measures of program effectiveness are limited to
1) statistical accounting of the numbers of inspections by county and type of practice; 2) some
notations about whether or not the facilities have been found to be in ( presumably significant)
non- compliance; and 3) recently by the addition of inspection quotas as part of the staff's
employee evaluations. While some information is often obtained during inspections of x- ray
facilities regarding the exposures received by patients from typical types of x- ray examinations, no
attempt has been made to compare this information to national averages which are routinely
published by the CRCPD, nor to present- this information in a public way.
Perhaps the most important impediment to developing an overall management plan for the two
programs is the lack of an effective and responsive data management program ( see below). The
current program is admittedly incomplete, however the inspection staff seem to want to return to
the " simple, old days" with a familiar but extremely limited data base system that could not be
easily modified for changes in the inspection process, nor could it be the kind of effective
program management tool required by modem management methods.
COMMENT: Operational plans should be developed. The registration, licensing and inspection
criteria should be grounded on public health and safety. These documents should be derived from
a series of management retreats with staff to clearly identify achievable goals. The plans should
be translated into individual personal goals and personal development plans. Staff training should
be part of the plan.
Recommendation # 2
Operational plans should be developed for the x- ray and radioactive materials programs.
The plans should include the following basic components: The problems; objectives;
methodologies; and evaluation. An inspection schedule should be developed
semiannually. The inspection frequency should be based upon the hazard and the
inspection history.
A written program plan with goals and objectives agreed upon by staff and management would
help to bring staff and management together in planning and priority setting so that the goals are
practical for them to achieve. There should be periodic staff meetings so that priorities can be
shifted if necessary to meet short- term goals. Potential short- falls can be identified in a timely
manner, and course corrections can be made before anyone goes too far away from the overall
direction.
-
If the goals are not coincident with staff career goals, then it will be clear that staff should
consider changing their position.
Recommendation # 3
CRITERIA: The RCP should be organized with the view toward achieving an acceptable
degree of staff efficiency, and placing appropriate emphasis on major program functions. It
should have adequate secretarial and clerical support.
FINDINGS: It is the practice of the program to be responsible for the billing and. colleeiion of
the fees charged radiation source registrants. This includes all aspects except the actual
maintenance of the funds in an account. At times, the program must hire temporary staff to
support the billing process. Since the funds are placed in the State treasury and are not available
to the program for use, there is no need for a separate account. At the same time, the effort
required by the staff to issue the bills and track payment and collection takes away from the staff
time available for the more important ( from a public health perspective) inspection and
compliance activities. While the program must continue to be involved in this activity because of
the need to assure accuracy in the billing process, there is no need for the staff to be responsible
beyond the most minimal activities required to assure accurate billing data transfer to a separate
billing and collection function.
,
Recommendation # 3
Effort should be made to minimize the radiation control staff workload requirements
to support the fee billing system. Alternatives to the current system should be
identified that are consistent with Arizona law and with the collection practices of the
State.
COMMENT: The current system not only requires the technical staff to accomplish
administrative functions significantly different from those necessary for their primary inspection
and compliance functions, it also requires an additional, if small, audit requirement on the
administrative support functions of the State. By combining the collection and audit functions
with other similar programs, administrative oversight and auditing requirements should be reduced
to an appropriate minimum. As with most States, the fees collected by the program have no
positive fiscal impact on the program and therefore no fiscal incentives for timely collection
management.
Recommendation # 4
CRITERIA: The Radiation Control Program should have a data management system that
provides an objective means for evaluating and demonstrating the public health and environmental
impacts of the program. It should also provide the data that is necessary for program planning,
evaluation, and efficiency. Statistical data from inspections should be developed to permit
program management to assess the status of the program on a periodic basis.
FINDINGS: The x- ray and radioactive materials programs previously used a data based program
to track licensing and compliance. The information provided by the computer program had been
based on input from staff. Because the old program was difficult to modify, and because it did
not contain necessary information or allow for the relational analysis to other data information
systems necessary for a modem regulatory program, a decision was made to convert and modify
the program to dBase IV. The new system is being programmed by a person( s) outside of the
agency. It does not function as desired or as necessary.
The fact that the program does not function properly has led to frustration. Additionally, some
staff do not appear to accept the need for an information system of the type that allows
comprehensive planning and evaluation of program activities that are necessary to achieve
efficiencies, or to justify program activities.
The program did have one FTE available for computer programming, but that position had been
eliminated.
Recommendation # 4
A functional management information system should be developed that will permit
the evaluation of 1) regulatory activities; 2) program effectiveness, e. g., patient,
worker and public dose assessments; and 3) program efficiency and consistency.
COMMENT: An integrated, flexible management information system is necessary in a
modem program in order to document the program's activities, to simplify administrative
procedures, and to obtain the data that is required to identlfy needed changes in program direction.
Before an adequate Operational Plan can be developed ( see above), a modem information
management system must be made available.
The Radiation Control Program should obtain the services of a data management system planner
to optimize the use of their computers. The development of an effective data management system
will be difficult unless the staff supports such a program and are committed to the utilization of
such a system once in place. As part of the development process, both management and staff
must evaluate what information is needed for the program to protect public health and safety in
the most effective and efficient manner. The system must be developed in a manner which
permits not only the current information needs of the program to be easily obtained by the staff,
but it should provide for easy updates and frequent and unique reports.
Statistical data from inspection and licensinglregistration activities should be developed to permit
the analysis of the status of the agency's programs on a periodic basis. A mechanism should be
established for periodic, detailed reporting of achievements and shortfalls, based on monthly
reports. The report of program activities should be widely circulated to enhance communications
within the agency, and with outside agencies and customers.
Recommendation # 5
CRITERIA: The x- ray program should have written procedures to insure that uniform inspections
are conducted. Inspections should be capable of determining whether a facility is in compliance
with the agency's regulations.
BINDINGS: The x- ray inspection reports do not document that facilities ' are in cornphnce with
all applicable regulations. Additionally, items that could improve image quality and reduce patient
exposure do not appear to be evaluated. For example:
While some reports reviewed had information about exposure rates in areas adjacent areas,
one of the survey meters used was not calibrated since 1993.
Reports did not document whether or not the facility had an ALARA program subject to
annual reviews.
It appears that no attention is being paid to the objective evaluation of film processing
techniques during routine inspections of all facilities.
Recommendation # 5
Inspection reports should be modified to assure inspection uniformity and to assure facility
compliance with regulations.
COMMENT: The inspections currently are rather basic and have not kept up with current
practices. Consistent and comprehensive inspections are needed to ensure that public health is
protected and that all facilities are being treated in a uniform manner. Additionally, data about
patient and radiation worker exposures could be collected and used to identify program
accomplishments, trends and needs.
Recommendation # 6
CRITERIA: The Radiation Control Program shall have regulations essentially in conformity with
the Suggested State Regulations for the Control of Radiation. Further, it is the Conference position
that States should obtain Conference recognition as a NARM Licensing State.
FINDINGS: While a detailed evaluation of Arizona smtes, regulations and procedures was not
conducted relative to the Licensing State criteria, it appears that Arizona should be able to meet
the Licensing State criteria It was determined that the state has not developed criteria relative to
allowing NARM from non- Licensing States into Arizona
The ARRA should initiate the necessary steps
to become a Licensing State.
COMMENTS: There is no federal or other uniform- regulation for the use of naturally
occurring or accelerator produced radioactive materials ( NARM). As a result of non- uniform
regulation of NARM, difficulties have developed for those states that have attempted to regulate
NARM. This creates potential public health and occupational safety consequences. Specifically,
states wishing to license NARM sealed sources/ devices manufactured in another state for which
there has been no validation of NARM licensing criteria or authority find it is difficult, if not
impossible, to license such items other than to issue a single license for each individual source or
device. Except for the Conference recognition of a State for the licensing of NARM, there is no
mechanism for the reciprocal recognition of a license to manufacture, since no validated license
exists. Likewise, there is no basis to accept, under reciprocity, a NARM licensee from another
state.
If Arizona obtained Conference recognition for the licensing of NARM, it would enable its
NARM licensees to work in other Licensing States under reciprocity. It would also provide the
program with a basis for evaluating requests for NARM source approval and reciprocity from
other states.
Arizona Non- Ionizing Program Review
Narrative Report
The CRCPD has published guidance for States in establishing an adequate program for the control
of hazardous sources of non- ionizing radiation, and the review team recommends thq this
guidance be followed. However, the review of this progam area in Arizona is listed io h e
varied experiences of the review team members.
Arizona's regulatory authority to control sources of non- ionizing radiation stems from the Title 30,
Chapter 4 sections authorizing other aspects of the program. The regulations controlling sources
of nonionizing radiation are found at Title 12, Chapter 1, Article 14 of the Arizona Administrative
Code. The sources specifically covered by regulation include laser sources, RF sources and
sources of ultraviolet radiation produced by electronic products. The statutory authority and the
regulatory framework appear to appropriately cover these sources and if these standards are
enforced will help to assure Arizona residents of protection from unnecessary and hazardous
exposures.
The staff

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PERFORMANCE AUDIT
ARIZONA RADIATION REGULATORY AGENCY
RADIATION REGULATORY HEARING BOARD
Report to the Arizona Legislature
By the Auditor General
October 1995
Report # 95- 8
DOUGLAS R. NORTON, CPA
AUDITOR GENERAL
STATE OF ARIZONA
OFFICE OF THE DEBRA K. DAVENPORT, CPA
DEPUTIIUDITOIIGLNLIIAL
Members of the Arizona Legislature
The Honorable Fife Symington, Governor
Mr. Aubrey V. Godwin, Director
Arizona Radiation Regulatory Agency
Dr. James Woolfenden, Chairman
Radiation Regulatory Hearing Board
Transmitted herewith is a report of the Auditor General, A Performance Audit
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory
Hearing Board. This report is in response to a May 5, 1993, resolution of the
Joint Legislative Audit Committee. The performance audit was conducted as
part of the sunset review set forth in A. R. S. 5941- 2951 through 41- 2957.
The report addresses the Agency's current inspection backlog for x- ray and
mammography machines. Reasons for this backlog include inefficient use of
staff resources and ineffective scheduling of inspections. For example, x- ray
and mammography machine inspectors spend an average of only one day a
week performing inspections. We recommend that Agency management shift
non- inspection duties from inspectors, which would allow them to spend more
time performing inspections. We also recommend that the Agency take
stronger and more timely enforcement action against radioactive materials
violations. We reviewed 81 cases with violations and found that the Agency
took some form of enforcement action in only 3 ( 4 percent) of those cases. The
Agency's inability to assess civil penalties due to a discrepancy within its rules
partially contributes to the limited enforcement. The report also presents other
2910 NORTH 44rH STREET . SUITE 410 . PHOENIX, ARIZONA 85018 I ( 602) 553- 0333 1 FAX ( 602) 553- 0051
Page - 2-
October 31, 1996
pertinent information regarding the statutes of the Southwestern Low- Level
Radioactive Waste Disposal Compact and alternatives for disposing of low- level
radioactive waste.
Finally, the report also addresses the statutorily mandated Sunset Factors for
the Radiation Regulatory Hearing Board.
My staff and I will be pleased to discuss or clarlfy items in the report.
This report will be released to the public on November 1, 1995.
Sincerely,
DO&& R. Norton
~ uditorG eneral
Enclosure
SUMMARY
The Office of the Auditor General has conducted a performance audit and sunset review
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing Board,
pursuant to a May 5,1993, resolution of the Joint Legislative Audit Committee. This audit
was conducted as part of the sunset review set forth in A. R. S. 9541- 2951 through 41- 2957.
The Arizona Radiation Regulatory Agency ( ARRA) is responsible for protecting the pub-lic
health, safety, and welfare by regulating the use and sources of radiation. ARRA ac-complishes
this responsibility by:
E Licensing and inspecting radioactive materials such as radioactive isotopes used in
the medical profession and gauges used to determine material content and density;
Registering and inspecting x- ray and mammography machines;
E Coordinating emergency response activities for any incidents, accidents, or emergen-cies
involving radiation in the State including the Palo Verde Nuclear Generating Sta-tion;
and
E Conducting laboratory functions to detect radiation levels in the State's air, water, and
soil.
Additionally, the Agency and its Director perform administrative and enforcement du-ties
assigned to the State by the Southwestern Low- Level Radioactive Waste Disposal
Compact.
The Radiation Regulatory Hearing Board, consisting of five appointed members, serves
as an independent check on the actions taken by the Agency. Licensees, registrants, or
individuals who wish to appeal ARRA actions may do so through the Board. Because the
Board has not met in the past two fiscal years, our work on the Board was limited to a
review and preparation of sunset factors ( see pages 33 through 35).
Failure to Perform Timely
X- Ray Inspections Threatens
Public Health and Safety
( See pages 5 through 13)
ARRA inspections protect the public from unnecessarily high and dangerous exposure to
man- made radiation and its detrimental health effects. However, the Agency currently
faces nearly a 30 percent inspection backlog for x- ray tubes, and over a 77 percent backlog
for mammography tubes.(') Beyond this backlog, several extreme examples of overdue
inspections exist. For example, two separate mammography machines have awaited in-spection
for two and five years, respectively. Similarly, a dental facility is almost four
years overdue for inspection.
Several reasons, including inefficient use of staff resources and ineffective scheduling of
inspections, contribute to ARRA's inability to meet its inspection schedule. For example,
x- ray machine inspectors, including mammography inspectors, spend an average of only
one day per week performing inspections. Much inspector time is consumed with admin-istrative
and registration activities that support staff could easily perform. Additionally,
ARRA's self- imposed mandate to conduct unannounced inspections wastes significant
time because inspectors arrive at facilities during times when machines are being heavily
used or when facilities are closed. Several states report that announced inspections re-duce
wasted time and, because of the nature of inspections, do not decrease their effec-tiveness.
Finally, for ARRA to address its inspection backlog and meet current inspection sched-ules
for x- ray and mammography machines, inspectors should increase the number of
machines they inspect. Several states, including Wisconsin, Oregon, and Louisiana, re-port
a much higher inspection rate per inspector than that achieved by ARRA inspectors.
Our analysis shows that the Agency can meet its inspection workload if inspectors per-form
a minimum average of 450 inspections per year, a rate comparable to that achieved
in other states.
Radioactive Materials
Enforcement Needs
Improvement
( See pages 15 through 22)
The dangerous nature of radioactive materials and the requirement that users adhere to
strict safety and administration policies and procedures demands a strong and consistent
enforcement stance. However, ARRA's untimely response to violations endangers the
' Tubes are the parts of x- ray machines that emit x- rays. Each machine may have more than one tube
and each tube requires inspection.
public health and safety. For example, even though prompt notification and correction of
violations is important, in nearly half of its cases, ARRA takes too long to notify licensees
of violations, gives the licensees too lenient a deadline to respond to the violation, and
then takes no action when over one- quarter of the licensees fail to respond by the dead-line.
In addition to untimely notification, ARRA rarely takes enforcement action when a viola-tion
occurs. Historically, ARRA has relied on civil penalties to enforce compliance with
its rules. From June 1992 through November 1993, the Agency assessed civil penalties
against 11 licensees. However, ARRA discovered a discrepancy within its rules govern-ing
civil penalties and the Attorney General advised the Agency to cease using civil pen-alties
until it could correct the discrepancy. As a result, several violations that merited
civil penalties, including at least 10 licensees with repeat violations and over 20 late lic-ensee
responses to notices of violation, were not assessed civil penalties.
The Agency's reluctance to use other available enforcement options further compounds
this problem. Statute and rule provides a range of enforcement actions that the agency
does not use, including license modification, informal hearings, injunctions, radiation
source impoundment, and license suspension or revocation. We reviewed 81 cases with
violations and found ARRA took some form of enforcement action in only 3 ( 4 percent) of
those cases.
ARRA's lenient enforcement philosophy partially contributes to its untimely and inad-equate
enforcement within the radioactive materials program. Both management and staff
display a preference to avoid strong enforcement actions, even when statute mandates
such actions.
( This Page Intentionally Left Blank)
Table of Contents
Page
Arizona Radiation Reaulatory Aaencv
Introduction and Background ............................................................... 1
Finding I: Failure to Perform Timely X- Ray
Inspections Threatens Public
Health and Safety ........................................................................... 5
Inspections of Man- Made Radiation
Sources Important ....................................................................................................... 5
Inspections Backlog
Plagues ARRA ............................................................................................................. 6
Poor Management of Staff
Resources Leads to Backlog ...................................................................................... 7
ARRA Could Perform
Many More Inspections .............................................................................................. 11
Recommendations ....................................................................................................... 13
Finding II: Radioactive Materials
Enforcement Needs Improvement ................................................... 15
Importance of Strong
Enforcement Program ................................................................................................. 15
Violation Notification
Is Not Timely ............................................................................................................... 16
RAM Enforcement
Is Not Adequate .......................................................................................................... 19
Lenient Philosophy Contributes
to Weak, Untimely Enforcement ............................................................................... 21
Recommendations ....................................................................................................... 22
Table of Contents
Pane
Arizona Radiation Requlatorv Aqencv ( con't)
Other Pertinent Information .............................................................. 23
History of Low- Level
Radioactive Waste ....................................................................................................... 23
Current Status of
Southwestern Compact ............................................................................................... 24
Impact and Alternatives ............................................................................................. 25
Sunset Factors ....................................................................................... 27
Radiation Requlaton, Hearinq Board
Introduction and Background ............................................................... 31
Sunset Factors ....................................................................................... 33
Agency Response
Tables & Figure
Table 1 Overdue X- Ray Inspections
According to ARRA's Inspections
Time Frame as of April 14, 1995 ..................................................... 6
Table 2
Table 3
Table 4
Figure 1
X- Ray and Mammography Tube Ins ections
Performed and Percentage of Time 2' pent on
Inspections Per Inspector, Fiscal Year 1994 ................................... 10
Average Number of X- Ray and
Mammograph Tubes Inspected
Per Inspector, $ i scal Year 1994 ....................................................... 12
Violation Notice and Licensee
Response Time Frames .................................................................... 18
Time Allocation by X- Ray/
Mammography Inspectors ............................................................. 8
INTRODUCTION AND BACKGROUND
The Office of the Auditor General has conducted a performance audit and sunset review
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing Board,
pursuant to a May 5,1993, resolution of the Joint Legislative Audit Committee. This audit
was conducted as part of the sunset review as set forth in A. R. S 5541- 2951 through 41-
2957.
ARRA and Hearing Board
Responsibilities
In 1980, the Legislature established the Arizona Radiation Regulatory Agency ( ARRA),
which replaced the Arizona Atomic Energy Commission. By creating ARRA, the Legisla-ture
wished to:
", . . protect the public health and safety by regulating the use and sources of
radiation. . . ."
ARRA is authorized to regulate man- made sources of radiation except those used by
federal agencies and certain nuclear reactors. Statutes provide authority for ARRA to
license or register such radiation sources, conduct inspections to ensure adequate compli-ance
with agency rules, and assess fees to registrants and licensees. Additionally, ARRA
has entered a special agreement with the Nuclear Regulatory Commission ( NRC) to con-trol
radioactive source materials, small quantities of special nuclear material, and radio-active
by- products from reactors. The agreement allows Arizona to provide local response
to radioactive materials emergencies as well as charge fees that are lower than NRC rates
to the State's radioactive materials users. The agreement also requires Arizona to follow
NRC regulations.
The Agency's additional statutory responsibilities include monitoring off- site radiation
in the air, water, and soil surrounding fixed nuclear facilities; responding to incidents,
accidents, and emergencies involving radiation; and performing administrative and en-forcement
duties related to the Southwestern Low- Level Radioactive Waste Disposal Com-pact,
to which Arizona, California, North Dakota, and South Dakota belong.
The Radiation Regulatory Hearing Board, consisting of five appointed members, is re-sponsible
for conducting hearings involving ARRA enforcement action appeals. The Board
may also review rules and regulations promulgated by ARRA and make recommenda-tions
to the Agency and the Legislature.
Organization
ARRA oversees five programs:
Radioactive Materials ( 4.5 FTEs) - This program oversees the licensing of 290 medi-cal,
industrial, and academic users of radioactive materials. For example, ARRA regu-lates
hospitals that use radioactive isotopes to perform diagnostic procedures and con-struction
companies that use gauges to determine material density. Program inspec-tors
conduct periodic site inspections, involving a review of policies and procedures,
treatment records, and material storage records, to ensure that licensees follow proper
techniques for the use, storage, and shipment of radioactive materials.
X- ray, Mammography, and Non- Ionizing Radiation ( 7.5 FTEs) - This program reg-isters
and periodically inspects 6,960 x- ray ( ionizing radiation) producing machines,
including medical, dental, and industrial radiography machines. Legislation adopted
in 1992 specifically requires annual inspection of the 210 registered, x- ray producing
mammography machines. This program also licenses and inspects non- ionizing radia-tion
sources, such as lasers and tanning beds.
Although the term " radiation" is very broad and includes such things as light and radio
waves, it is most often used to mean " ionizing" radiation, which is radiation that can
produce charged particles (" ions") in materials that it strikes. Ionizing radiation can
present a health hazard to the public. Non- ionizing radiation may also pose a health
risk, although the extent of this risk is not well known or documented and is more
inconclusive than its ionizing counterpart.
Environmental Surveillance Laboratory ( 7 FTEs) - The lab maintains surveillance
over radiation levels near Palo Verde Nuclear Generating Station ( PVNGS), as well as
other areas such as the Navajo Reservation, where radiation levels in the water have
been notably high. Surveillance includes the sampling of air, water, and soil. This
program also provides public information and technical assistance in assessing radon
in Arizona.
Emergency Response ( 2 FTEs) - The Emergency Response program provides tech-nical
assistance to handle any incidents, accidents, or emergencies involving radiation
or sources of radiation within the State. The program also prepares for and partici-pates
in off- site radiation emergency response at PVNGS. Additionally, the program
provides first response training for police, fire, and medical personnel who may re-spond
to accidents.
Medical Radiologic Technology Board of Examiners ( MRTBE) ( 2 FTEs) - MRTBE
certifies operators of medical radiologic equipment by requiring minimum training
and experience.
Budget and Personnel
ARRA's operating budget consists of both appropriated and nonappropriated funds. The
Agency expended over $ 1.5 million in appropriated funds and over $ 270,000 in federal
funds in fiscal year 1994- 95. The $ 1.5 million in appropriated funds represents approxi-mately
$ 1 million from the general fund, $ 399,000 from the Nuclear Emergency Manage-ment
Fund ( NEMF), and $ 102,000 from the State Radiologic Technology Certification
Fund. The Legislature established the NEMF to fund Arizona's nuclear generating sta-tion
emergency response activities. The consortium that operates PVNGS reimburses the
State for amounts appropriated to this fund by the Legislature. The State Radiologic Tech-nology
Certification Fund reflects fees radiology technicians pay to become certified by
the State.
In addition to the FTE numbers indicated for each program, the Agency is authorized 5
FTEs for administration/ support staff and 1 FTE for the Director, for an authorized total
of 29 FTEs. Each program within the Agency reports to a program manager, with the
exception of the radioactive materials ( RAM) and x- ray programs, which are managed by
a single program manager.
Audit Scope
This audit focuses on the need for the Arizona Radiation Regulatory Agency and its ef-forts
to protect the public health and safety from dangers associated with sources of ra-diation
and their use. We also performed limited work on the Radiation Regulatory Hearing
Board which is found in the sunset factors. The Medical Radiologic Technology Board
was not reviewed as part of this audit since it is scheduled for sunset review as part of the
1997 audit cycle.
Our work included a review of the Agency's ability to perform timely inspections of x-ray
machines and radioactive materials, adequacy and timeliness of all enforcement ac-tions
it takes, ability to respond effectively to radiation emergencies, complaint handling,
and current status of the Southwestern Compact for Low- Level Radioactive Waste dis-posal.
Additionally, we contacted ten states, the Conference for Radiation Control Pro-gram
Directors ( CRCPD), and the Nuclear Regulatory Commission.(')
While our work found problems, we also found that ARRA is performing well in some
areas. Unlike x- ray inspections, ARRA performs radioactive materials inspections in a
timely manner. Additionally, while we found problems in radioactive materials license
We contacted radiation officials in states with a similar number of registered x- ray tubes and/ or an
agreement with the Nuclear Regulatory Commission to control radioactive source materials. States
contacted were North Carolina, Minnesota, Maryland, Oregon, Tennessee, Louisiana, Oklahoma, Wis-consin,
Colorado, and Washington.
enforcement, we found minimal problems pertaining to x- ray enforcement. Also, we de-termined
that the Agency responds adequately to radiation emergencies and/ or inci-dents
as demonstrated by its response to a Tucson incident, reviews it has received on
past Palo Verde Nuclear Generating Station response exercises, and previous Auditor
General and federal inspection comments regarding the Agency's response abilities.
Our report presents findings and recommendations in two areas:
The need for improved productivity in ARRA's x- ray/ mammography program in
order to eliminate inspection backlogs.
H The need for more frequent, timely, and aggressive enforcement actions against lic-ensees
who violate radioactive materials regulations.
In addition to these audit areas, we present other pertinent information concerning the
status of the Southwestern Low Level Radioactive Waste Disposal Compact and alterna-tives
for disposing low- level radioactive waste. This report also contains responses to the
12 Sunset Review Factors for the Agency ( see pages 27 through 30) and for the Radiation
Regulatory Hearing Board ( see pages 33 through 35).
The findings in this report are similar to those in our previous report on the Radiation
Regulatory Agency and Radiation Regulatory Hearing Board which was issued in No-vember
1984. That audit found that the Agency did not conduct all its inspections in a
timely manner, it could take stronger or more timely enforcement actions, and that the x-ray
machine registration and fee collection process could be improved. The report also
noted that the Agency had not received sufficient funding from the Nuclear Emergency
Management Fund ( NEMF) to finance its costs relating to Palo Verde Nuclear Generating
Station activities.
This audit was conducted in accordance with government auditing standards.
The Auditor General and staff express appreciation to the Director, staff, and board mem-bers
of the Arizona Radiation Regulatory Agency and the Radiation Regulatory Hearing
Board for their cooperation and assistance throughout the audit.
FINDING I
FAILURE TO PERFORM TIMELY X- RAY
INSPECTIONS THREATENS PUBLIC HEALTH
AND SAFETY
X- ray machine ( including mammography machine) inspections should occur at regular
intervals to protect the public from unnecessary radiation exposure. However, nearly 30
percent of x- ray tube and over 77 percent of' mammography tube inspections are past
due. Because staff time and activities are poorly managed, inspectors spend an average of
only one day a week performing inspections. ARRA's management should strive to meet
other states' productivity levels by reducing staff time spent on tasks other than inspec-tions,
holding inspectors accountable for number of inspections performed, and schedul-ing
inspections more efficiently.
ARRA's 5 x- ray inspectors conduct inspections of 3,393 facilities with registered x- ray
tubes. Such facilities include medical, dental, veterinary, and chiropractic offices; hospi-tals;
and industrial facilities. During inspections, inspectors monitor the amount of radia-tion
emitted from each x- ray tube, the adequacy of radiation barriers such as walls, and
the quality of the x- ray images taken. Additionally, ARRA has trained 2 inspectors to
perform inspections of mammography machines at an additional 156 facilities. These in-spections
must conform to the United States Food and Drug Administration ( FDA) stan-dards.(')
Inspections of Man- Made
Radiation Sources Important
ARRA inspections are necessary to protect the public from unnecessarily high and dan-gerous
exposure to ionizing radiation and its detrimental health effects. Even though x-ray
inspections yield nearly a 91 percent compliance rate, the health threat posed by tubes
that emit too much radiation mandates a comprehensive and timely inspection program.
According to the National Research Council, ionizing radiation's " well demonstrated late
effects include the induction of cancer, genetically determined ill- health, developmental
abnormalities, and some degenerative diseases such as cataracts." c2)
' ARRA has a contract with the FDA to perform inspections in accordance with the Mammography
Quality Standards Act of 1992. Such inspections also satisfy Arizona statutory requirements for
mammography machine inspections.
( 2) Health Effects of Exposure to Ionizing Radiation, National Research Council, National Academy Press,
Washington, D. C., 1990.
Ensuring the safety of x- ray tubes is critical since the healing arts ( x- ray and nuclear medi-cine)
represent approximately 83 percent of the U. S. population's total exposure to man-made
ionizing radiation. Also, in recent years, the importance of mammography inspec-tions
has been increasingly stressed due to the large number of women ( one in eight) who
develop breast cancer over the course of a lifetime.
lnspections Backlog
Plagues ARRA
ARRA fails to conduct x- ray and mammography inspections in a timely manner. Inspec-tions
are required at regular intervals established by the Agency itself and by statute.
Nonetheless, hundreds of ARRA's registered x- ray and mammography tubes are over-due
for inspection.
X- ray inspections far behind schedule - ARRA does not keep current with its own schedule
for registered x- ray tube inspections. This schedule requires that inspections occur at regu-lar
intervals from two to four years based on the type of facility where the machine is
used. However, nearly 30 percent of x- ray tube inspections are late according to ARRA's
timetable for inspections, as shown in Table 1.
Table 1
Overdue X- Ray lnspections According to
ARRA's lnspections Time Frame
as of April 14,1995
Hospital Every Two Years 1,036 575 55.5%
Medical
Educational Every Three Years 1,796 528 29.4%
Chiropractic
Dental
Veterinary
Industrial
Podiatry
Total
Every Four Years
Source: Auditor General analysis of ARRA database as of Apnl14,1995.
Our analysis also found many extreme examples of overdue inspections, including:
A Sierra Vista dental facility that is almost four years overdue for inspection. Since
the inspection due date, the facility has taken an estimated 63,200 x- rays.
W Two Tucson hospitals that were almost three years overdue for inspection. Since our
initial analysis, ARRA subsequently inspected one hospital and found that one
machine's radiation filtration was inadequate, resulting in excessive radiation expo-sure.
An Ajo dental facility that went 17.7 years between inspections. Even though this
facility is open only twice a month, which may warrant a more lenient inspection
schedule, ARRA's director indicated the facility should be inspected every 8 to 12
years.
Mammography inspections also overdue - Like other types of x- ray inspections, many
mammography inspections are also past due. Since September 1992, state statute has re-quired
yearly inspections of mammography machines. ( Previously, mammography in-spections
occurred as part of ARRA's routine inspection of x- ray facilities.) Nonetheless,
ARRA has failed to perform these inspections as required. One- hundred sixty- one of the
208 registered mammography tubes ( 77 percent) are overdue for inspection, with 72 tubes
( 35 percent) overdue by more than one year. Extreme examples of overdue inspections
also exist. For instance, ARRA has not inspected a mammography machine in a rural
hospital for over three years and a Maricopa County gynecologisl!~ machine for over six
years. Since their last inspections, an estimated 19,500 and 45,460 mammography expo-sures
have occurred at these facilities.
Poor Management
of Staff Resources
Leads to Backlog
Management's failure to maximize the time inspectors devote to inspections contributes
to the current x- ray inspections backlog. ARRA inspectors currently devote less than 20
percent of their time to inspections, instead devoting time to administrative tasks. Addi-tionally,
management's failure to hold inspectors accountable for the quantity or quality
of inspections further affects the number of inspections performed. Furthermore, the ab-sence
of advanced scheduling of x- ray inspections thwarts the number of inspections that
can be performed.
Small percentage of time dedicated to inspections - Inspectors dedicate few hours to
inspections, thus contributing to inspection backlogs. As shown in Figure 1 ( see page 8),
x- ray and mammography machine inspectors spend 20 percent of their time, or only one
( This Page Intentionally Left Blank)
40 percent of her time handling administrative duties that should be performed by
this manager. These duties include writing contracts, writing employee evaluations,
and reviewing inspections completed by other inspectors. Therefore, this inspector
spent only 19 percent of her time conducting inspections during the 21- month period
ending March 31,1995. If the program manager resumed performing these adminis-trative
duties, this inspector could spend more time performing inspections.
Subsequent conversations with the program manager and the Director did not ad-equately
explain why the program manager spends little time administering the x- ray
program he is charged with overseeing. Although the program manager explained he
has additional duties involving power line siting and the Southwestern Low- Level
Radioactive Waste Compact, these tasks should not detract from his primary respon-sibilities
as program manager.
Inefficient record- keeping - Inspectors spend unnecessary time updating inspec-tion
records. This problem results from management's failure to use support staff for
this task. Additionally, problems with the computerized database contribute to ineffi-ciencies
as inspectors record inspection information on two databases, a card file, and
a case file. ARRA management recently began addressing the former problem by shift-ing
more record- keeping. tasks to existing support staff.
Time wasted on registration - Inspectors unnecessarily spend nearly 20 percent of
their time registering x- ray machines. Rather than requiring x- ray machine owners to
be responsible for providing and updating all the necessary information to register
their machines, inspectors do much of this clerical work. Inspectors personally gather
registration information during inspections and update registration forms between
inspections when registrants provide new or updated information. These processes
could better be handled between the x- ray machine owners and ARRA's support staff,
freeing inspector time for their primary duties. ARRA management cited staff errors,
incorrect registration reporting by x- ray machine owners, and data entry performed
by inspectors rather than support staff as reasons for the significant amount of time
spent on registration.
Time spent on fee collection - Administrative activities include time spent by x- ray
inspectors on annual fee collection from registrants. Interviews with inspectors sug-gest
that support staff can perform most fee collections activities, including updating
change of address information to ensure accurate billings.
In order to shift additional administrative activities to support staff, management should
assess the adequacy of its current support staff levels. If existing support staff is inad-equate,
ARRA could consider hiring additional permanent staff or temporary support
staff. Both ARRA and one of ARRA's divisions, the Medical Radiologic Technology Board
of Examiners, already hire some temporary staff to assist with fee collection, thus allow-ing
them to handle this task without the addition of permanent support staff.
Management neglects to hold inspections staflaccountable - When staff devote more
time to inspections, inspection rates increase, as shown in Table 2. The ARRA inspector
who spent the most time ( 37 percent) on x- ray inspections performed over 550 x- ray tube
inspections. Nonetheless, management does not hold inspectors accountable for time spent
on inspections, the types of inspections each inspector performs ( inspections of some types
of facilities take longer than others), nor the actual number of inspections accomplished.
In other states such as Louisiana and Minnesota, goals are set for the number of inspec-tions
each inspector must perform. While Arizona's program has set inspection goals in
the past, management has not adequately considered these goals in performance evalua-tions.
Table 2
X- Ray and Mammography Tube Inspections Performed and
Percentage of Time Spent on lnspections Per Inspector,
Fiscal Year 1994(")
Inspector One
Inspector Two
Inspector Three
Inspector Four
(") A fifth inspector was added in July 1994, and a sixth inspector will be added in fiscal year 1995- 96.
The unit also employs a non- ionizing x- ray ( lasers and tanning beds) inspector and shares its pro-gram
manager with the Radioactive Materials units.
Source: Auditor General analysis of ARRA x- ray inspection records and time sheets for fiscal year
1994.
Management also does not hold staff accountable for the quality of inspections. Inter-views
suggest that one inspector continuously makes mistakes during routine inspec-tions,
thus requiring other inspectors to check his work or repeat these inspections. These
mistakes include his failure to note serious machine problems that could result in exces-
sive radiation exposure. While the compliance program manager acknowledges that the
quality of this inspector's work is problematic, performance evaluations have not charac-terized
his work as unacceptable.
Lack of scheduling leads to wasted time - Further compounding productivity prob-lems,
unannounced or unscheduled inspections contribute to wasted time. Based on our
observations, inspectors often arrive at facilities for unannounced inspections when the
offices are closed or extremely busy, forcing inspectors to wait or return at more conve-nient
times. In these instances, we documented much time wasted. Also, the lack of basic
information in ARRA's files, such as a facility's hours of operation, partially contributes
to this problem.
ARRA's Director indicated that an interagency agreement between the Industrial Com-mission
( ICA) and ARRA prohibits announced inspections.( l) However, interviews with
ICA officials revealed that announced inspections do not violate any such agreement.
Other states such as Louisiana, Minnesota, Wisconsin, Washington, and Maryland per-form
announced inspections. Additionally, our observations suggest ARRA could do the
same without decreasing quality since facility staff are 1) generally unaware of problems
with their machines and 2) often eager to learn about any problems. Hence, announced
inspections should not be any less effective than unannounced inspections.
ARRA Could Perform
Many More Inspections
ARRA's average x- ray inspection rate compares poorly to inspection rates achieved in other
states. If ARRA improved its inspection rate, it could meet its schedule for performing x- ray
machine inspections, as well as the statutorily defined schedule for mammography machine
inspections.
As seen in Table 3 ( see page 12), productivity rates for six of the seven states reporting this
data exceed the average number of inspections performed by ARRA inspectors during
fiscal year 1994. Four states exceed an average staff inspection rate of 450 tubes per year.
While differences exist between states regarding inspection procedures due to a lack of
federal or nationally mandated inspection procedures or standards, these states indicated
they do conduct comprehensive x- ray machine inspections. These inspections not only
cover the quality, safety, and accuracy of the machines themselves, but also encompass
safety procedures for and the protection of workers, the general public, and the environ-
This agreement recognizes ARRA's authority in conducting inspections of facilities that handle radia-tion
in order to protect workers from unnecessary radiation exposure.
ment. All of these states have adopted regulations for x- ray machines that are similar to
the Conference of Radiation Control Program Directors ( CRCPD) suggested state regula-tions
and/ or FDA performance standards for machines. Additionally, a CRCPD official
commented that inspectors in other state programs usually inspect 400 to 500 tubes annu-ally.
ARRA's management states that 600 annual tube inspections should be an achievable
goal for each inspector. Indeed, one ARRA inspectofs productivity rate of 556 inspec-tions
per year achieved at only 37 percent time spent on inspections ( see Table 2, page 10)
suggests that such a goal is attainable. The official from the CRCPD noted that some states
exceed such figures, particularly states with high concentrations of x- ray facilities in large
metropolitan areas. For example, in Wisconsin, a state that, like Arizona, has two- thirds
of its x- ray tubes in one large metropolitan area, inspectors accomplished an average of
886 tube inspections in fiscal year 1994.
If ARRA x- ray inspectors performed as few as 450 annual inspections, we estimate that
the Agency could meet its inspection schedule. ARRA could devote 1.5 FTEs to
mammography machine inspections and still perform the 2,384 state x- ray inspections
required on average each year according to ARRA's current timetable for inspections.(')
Table 3
Average Number of X- Ray and Mammography Tubes
Inspected Per Inspector, Fiscal Year 1994
Wisconsin
Oregon
Louisiana
Washington
North Carolina
Minnesota
Arizona
Tennessee
Source: Auditor General interviews of radiation program officials in other states and analysis of ARRA's
fiscal year 1994 inspection figures.
' Our estimate is based on the addition of two inspectors that are authorized to be added by fiscal year
1997. Also, 1.5 FTEs are necessary for performing the 210 annual tube inspections since mammography
inspections take considerably longer than other x- ray inspections. Additionally, the program has ex-perienced
an annual growth rate of 60 to 70 tubes for the past few years. If this growth continues, x- ray
inspectors would need to perfom more than 450 annual inspections in future years and/ or ARRA
would need additional inspectors.
RECOMMENDATIONS
1. ARRA should shift administrative and registration duties from x- ray inspectors to
management and support staff. Management should consider whether additional sup-port
staff is necessary, and consider the hiring of temporary clerical staff to perform
duties associated with seasonal fee collection.
2. Management should hold inspectors accountable for number and types of inspections
accomplished and/ or time spent performing inspections. Also, management should
establish performance goals as is done in other states.
3. X- ray inspections should be performed on an announced, prescheduled basis.
( This Page Intentionally Left Blank)
FINDING II
RADIOACTIVE MATERIALS ENFORCEMENT
NEEDS IMPROVEMENT
While radioactive materials ( RAM) inspections appear to be timely and adequate, RAM
enforcement actions are slow and inadequate. Our review of agency enforcement revealed
instances where the RAM program took excessive amounts of time to begin and complete
enforcement actions, including instances extending well over a year. Further, we identi-fied
cases that may have merited stronger enforcement action. The Agency's inability to
assess civil penalties and its lenient enforcement philosophy contributes to untimely and
weak enforcement.
Per agreement with the Nuclear Regulatory Commission, ARRA has direct oversight re-sponsibilities,
including licensure, inspection, and enforcement for radioactive materials.
Uses for radioactive materials include soil- and asphalt- testing gauges, industrial and
medical imaging, and research activities. ARRA conducts inspections of radioactive ma-terials
at different intervals based on the user's license and type of radioactive material in
use. Inspections include an examination of the user's policies and procedures, treatment
records, and radiation safety activities. An inspector will also observe personnel using or
administering radioactive material.
Importance of Strong
Enforcement Program
As noted previously, adequate and timely enforcement is important because research has
shown that exposure to sources of radiation can harm the public health and safety. Al-though
it is impossible to predict the amount of radiation exposure necessary to cause
damage, it is critical to reduce the amount of radiation received by the public to reason-ably
achievable low levels. Consequently, ARM efforts to enforce compliance with its
rules and regulations become extremely important. These efforts should ensure that ra-dioactive
materials users do not endanger the public health. The following example illus-trates
the importance of ensuring compliance with ARRA rules.
In November 1989, a Phoenix hospital incorrectly administered a radioactive treat-ment
that destroyed a woman's thyroid gland. As a result, the woman received more
than 1,000 times the intended dose and inadvertently exposed her children to radia-
tion. Following this misadministration, ARRA conducted an investigation and deter-mined
that the technician on duty did not comply with rules that require confirmation
of the prescription and dosage before giving it to the patient. Although ARM as-sessed
a $ 12,000 civil penalty, this woman faces an increased risk for developing can-cer
and must now medically treat her condition for life.
Violation Notification
Is Not Timely
ARM fails to act promptly on radioactive materials violations. Under ARRA's agree-ment
with the NRC, ARRA must abide by NRC regulations that require it to notify licens-ees
of violations within 30 days. However, ARM frequently misses these deadlines.
Additionally, many licensees also respond late to notices of violation. Excessive report
review and lack of procedures for ensuring timely violation notices and responses con-tribute
to delays.
Notification and response correspolsdence are slow - Notices of violation are untimely.
NRC regulations require that Arizona notify licensees of violations within 30 days fol-lowing
an inspection. We conducted a file review of 80 RAM licensee files with viola-tions,
and determined that on average ( excluding four files for abnormally late notices),
ARRA sends notices of violation to licensees in 33 days. While this average does not greatly
exceed the NRC requirement, we also determined that for 37 of the 80 files ( approxi-mately
46 percent), ARRA mailed notices late, effectively delaying prompt resolution of
violations. Additionally, ARRA transmitted several notices extremely late, including 4
mailed from approximately 74 to 380 days later than the 30- day requirement. Late viola-tion
notices can negatively affect the Agency's ability to enforce its regulations as illus-trated
by the following case examples.
A medical facility received ARRA's notice of violation 410 days after an inspection.
Violations resulted from not checking incoming packages for radioactive material leak-age,
and the radiation safety officer's failure to properly oversee the program. As a
result of this late violation notice, the licensee demanded an explanation for the delay.
The licensee also questioned how, if it had committed violations, the public's welfare
could be protected by the Agency's delay in transmitting the results of the inspection.
ARRA eventually apologized for the late violation notice.
A nuclear medicine supplier received a notice of violation 60 days after an inspection.
The licensee had failed to monitor radiation levels in clothing after performing a medical
radiation procedure. In their response, the licensee pointed out that ARRA dated the
notice almost one month before mailing it. The response also noted the unfairness of
giving a licensee less time to respond than ARRA took to transmit the violation.
In addition to informing licensees of violations in an untimely manner, ARRA often re-ceives
late responses to violation notices. ARRA requires a licensee response to ensure
licensees appropriately address violations, explain why the violation occurred, and detail
steps it will take to prevent its recurrence. However, approximately 26 percent of licens-ees
responded later than ARRA's 40- day requirement, further delaying timely resolution
of the violation. On average, ARRA received these late responses 13 days beyond the 40-
day deadline. Additionally, ARRA received several responses over two months late. Ac-cording
to the RAM program manager, licensees may have violations with severe health
and safety ramifications that require a rapid response. For example:
An industrial company responded to a violation notice 98 days following its receipt.
An ARRA inspection found three violations, including the licensee's failure to con-duct
leak tests on radioactive materials and perform physical inventories of its radio-active
materials at least every six months. The licensee had repeated these two viola-tions
from its previous inspection. Even though these violations and their repeat na-ture
indicate potential problems with the licensee's radiation safety program, ARM
made no effort to ensure a timely response, nor did it take action for the untimely
response.
ARRA's 40- day response deadline also appears lenient. NRC guidelines recommend that
licensees respond to a violation notice within 20 to 30 days following its receipt. Addi-tionally,
Table 4 ( see page 18) shows that Kentucky, Maryland, Tennessee, and Oregon
require licensee responses within at least 20 days. ARRA has submitted a proposed rule
changing the 40- day response deadline to 30 days and is currently awaiting Attorney
General approval.
Table 4
Violation Notice and Licensee
Response Time Frames
ARRA
NRC
Strives for 30 days after inspection
Specifies 30 days
CRCPD Recommends 30 days
Oregon Mailed within 20 days after
inspection
Kentucky Attempts to mail within 14 days
after inspection
Tennessee
Maryland
Mailed within 15 days after
inspection
Might send a notice as soon as
4 days after an inspection with a
report to follow
Requires response within 40 days
Recommends 20 to 30 days
Recommends 30 days
Requires response within 20 days
after receiving notice of violation
Requires response within 15
days after receiving notice'of
violation
Requires response within 15
days after receiving notice of
violation
Requires response within 20
days after receiving notice of
violation
Source: Auditor General interviews of radiation program officials in other states and review of NRC
and Conference for Radiation Control Program Directors ( CRCPD) documentation.
Untimely review and lack of procedures lead to delays - Untimely report review im-pairs
ARRA's ability to act quickly upon finding violations. Before mailing a notice of
violation, the inspector must have his work reviewed by at least one co- worker, the pro-gram
manager, and ARRA's Director. While the manager points to delays with inspec-tors,
inspectors commented that management contributes to delays due to indecisiveness
regarding possible actions against licensees. Additionally, the program manager indi-cated
that his workload causes delays as do reports that are routed through the Attorney
General. The Director also indicated that technical issues, which require additional re-
search or laboratory work, frequently delay the completion of violation notices. How-ever,
the agency can and should transmit notices in a timely manner and indicate on
notices where required that additional follow- up may be needed. This would allow ARRA
to remain timely, but ensure all issues are adequately addressed.
Additionally, ARRA should institute procedures to ensure the timely completion and
transmittal of violation notices within 30 days. Currently, ARRA has no procedures gov-erning
the review process and detailing when all levels of review are needed, how much
time each review stage should take, and when Attorney General review is needed. Ac-cording
to the CRCPD, radiation programs should have written procedures for response
to licensee noncompliance.
RAM Enforcement
Is Not Adequate
In addition to untimely notification, ARRA enforcement actions against licensee viola-tions
are virtually nonexistent. Historically, ARRA has at times used civil penalties as its
primary enforcement tool; however, civil penalties are currently unenforceable. As a re-sult,
ARRA took action against only 4 percent of licensees with violations during July 1,
1993, through December 31,1994, even though several merited strong enforcement ac-tion.
Additionally, the Agency has not made use of other available enforcement options.
Civil penalties are currently unenforceable - Historically, ARRA has relied on civil pen-alties
to ensure compliance with its rules and regulations; however, ARRA currently can-not
enforce its civil penalties. A. R. S. 5530- 687 and 30- 688 provide ARRA the authority to
assess civil penalties. Through rule the Agency has set the penalty range from $ 250 to
$ 4,000 per violation. ARRA used civil penalties until November 1993, at which time the
Agency discovered an internal discrepancy within its rules governing the assessment of
civil penalties. As a result, the Attorney General advised ARRA that it should cease as-sessing
civil penalties until the rule discrepancy could be corrected. While we agree that
ARRA acted appropriately in ceasing to assess civil penalties, more than 12 months passed
before it submitted draft rules to the Governor's Regulatory Review Council for review.
At this time, the amended civil penalty rules are in the State's rule approval process.
Until ARRA discovered the rule discrepancy, it had imposed 11 separate civil penalties
between June 1992 and November 1993. However, since that time at least ten licensees
with repeat violations that warranted civil penalties have not been assessed automatic
civil penalties due to the rule discrepancy.
ARRA enforcement is inadequate - In our review of inspections that ARRA performed
during the 18- month period July 1,1993, through December 31,1994, ARRA took enforce-
ment action against only 4 percent ( 3 of 81 cases) of licensees with violations. While ARRA's
inability to use civil penalties partially explains the lack of enforcement actions, it appears
that the Agency often takes little action beyond sending the notice of violation and ob-taining
the licenseers written response. Our review found that several cases deserved
stronger enforcement action, which ARRA did not take. For example:
A recent inspection at a large hospital yielded 8 violations and 13 items of concern.
( Items of concern can lead to violations in the future if not corrected.) ARRA con-ducted
the inspection after the hospital lost a minor radiation source used for medical
purposes. ARRA found multiple violations that directly contributed to the loss of the
radiation source, including not taking inventory of the source after the procedure, and
allowing an untrained doctor to complete the removal of the source from a patient.
The source was never found, and is believed to be buried in a landfill.
The licensee has a history of numerous violations and items of concern. ARRA has
repeatedly found the same items of concern related to radiation- contaminated areas
in laboratories and a pharmacy ( four times), and radioactive trash included with regular
or unmarked trash. These items of concern, which would have been violations if the
level of radioactivity had been higher, indicate carelessness on the part of the licensee
and are important because the contamination can end up in public areas.
The numerous violations and items of concern merit some type of enforcement action.
However, in three inspections that found violations between 1988 and 1994, ARRA
took no action.
Another large hospital has performed four radiation source misadministrations from
1989 through 1993. In 1989, a patient in the hospital received the wrong radioactive
diagnostic medication. In 1991, a patient was mistakenly given the radioactive medi-cation
intended for his hospital roommate. In 1992, a tube containing radioactive ma-terial
exposed a patient and nurse to a small amount of radiation for approximately an
hour. Finally, in 1993, another misadministration of radioactive medicine occurred.
Despite this history of misadministration and numerous violations, including one re-peat
violation found during an inspection in 1993, ARRA has never taken enforcement
action against this licensee.
ARRA seldom uses enforcenrerzt options - ARRA has many enforcement tools at its dis-posal,
but seldom makes use of them. Based on our file review, ARRA assessed civil
penalties against 3 of 15 licensees with repeat violations, but did not take action against
the remaining licensees nor a licensee with a severe violation which involved falsifying
radiation safety records. Additionally, ARRA did not take enforcement action against
any of 21 licensees that provided late responses to notices of violation.
Other than civil penalties, which are currently unavailable, ARRA rarely takes enforce-ment
action. Statute and rule provides a range of enforcement actions that the Agency can
use including license modification, informal hearings, injunctions, radiation source im-poundment,
and license suspension or revocation. However, the program manager indi-cated
that ARRA has modified licenses only four or five times during the Agency's exist-ence.
In addition, ARRA uses informal hearings to communicate the imposition of civil
penalties, rather than an enforcement tool itself to encourage prompt violation resolution
and compliance with rules and regulations. Moreover, the Agency has never used injunc-tions,
radiation source impoundments, license suspensions, and/ or revocations.
Other agencies employ a variety of enforcement tools to ensure compliance with their
rules and regulations. For example, the Arizona Department of Environmental Quality
( ADEQ) uses consent agreements and compliance orders to enforce compliance with its
rules and regulations. Consent agreements offer many benefits, including a court- enforce-able
order which both parties agree to and understand their obligations. Compliance or-ders
differ in that the Agency mandates compliance; however, the licensee retains the
right to appeal. In explaining their preference to use consent and compliance orders, an
ADEQ official indicated that the Agency wants licensees to spend their money to return
to compliance, rather than paying an administrative penalty.
In addition to these enforcement tools, ARRA might also ensure licensees correct identi-fied
violations through follow- up inspections and/ or an accelerated inspection schedule.
The RAM program rarely performs follow- up inspections, although the Conference for
Radiation Control Program Directors recommends that agencies do so. Additionally,
Kentucky, Maryland, and Oregon conduct follow- up inspections and/ or accelerate the
licensee's inspection schedule to ensure licensees return to and remain in compliance.
Lenient Philosophy Contributes
to Weak, Untimely Enforcement
ARRA's untimely and inadequate enforcement of the radioactive materials program re-sults
in part from the Agency's accommodating relationship with the regulated commu-nity.
Instead of mandating licensee compliance with its rules through a strong enforce-ment
attitude, ARRA prefers to work with licensees in an effort to arrive at compliance.
While maintaining good working relationships with licensees is beneficial, it should not
detract from the Agency's primary mission of regulation. The program manager indi-cated
they do not want licensees to suffer monetary setbacks and prefer to use other en-forcement
methods. However, based on our review of inspections performed between
July 1, 1993, through December 31, 1994, the Agency did not take enforcement action
against the majority ( 96 percent) of licensees with inspection violations. Additionally, in
our November 1984 report on the Agency, we commented on its lenient enforcement
philosophy, noting that ARM feared damaged working relationships with licensees if it
pursued strong enforcement action.
This philosophy toward enforcement filters down to some RAM staff. In one of its re-views,
NRC found inspectors inappropriately issuing items of concern instead of viola-
tions because of inspector perceptions that penalties are too severe. Items of concern iden-tify
problems that can lead to violations if not remedied. The following case example
illustrates ARRA's reluctance to take enforcement action.
H A licensee ( a city) repeated a violation ( failure to perform leak tests) from a previous
inspection, thus meriting a mandatory $ 1,250 civil penalty. After receiving and re-viewing
the city's response, ARRA notified it that the response did not provide a basis
for mitigating or waiving the proposed civil penalty. If the city did not appeal this
order within 20 days, the civil penalty would be assessed. No appeal was received.
However, the inspector, who was under the impression that this city faced bankruptcy,
advised it that ARRA might not impose the civil penalty if they disposed of the par-ticular
piece of equipment involved. The licensee sold the equipment almost five months
later and ARRA dropped the mandatory civil penalty.
Despite disposal of the equipment, ARRA violated its own rule in dropping the pen-alty.
While the rule provides for penalty mitigation if the licensee responds in a timely
manner, the rule specifically states that in the case of repeat violations, the penalty
cannot be avoided by compliance. ARRA has submitted a rule change that will allow
the agency to mitigate penalties in the case of repeat violations. This change currently
awaits Attorney General approval.
RECOMMENDATIONS
1. ARRA should send licensees notices of violations within 30 days after inspection.
2. ARRA should complete revisions to the civil penalties rules and ensure their contin-ued
validity.
3. Once civil penalties are again available, ARRA should impose civil penalties as in-tended
by the regulations on repeat violators and on licensees with late responses to
notices of violation.
4. ARM should use other enforcement actions, including consent agreements, compli-ance
orders, and informal hearings. The Agency should also consider performing fol-low-
up inspections and accelerating the inspection schedule for licensees with viola-tions.
OTHER PERTINENT INFORMATION
During the audit, we collected information regarding the status of and alternatives to the
Southwestern Compact, an agreement between California, Arizona, North Dakota, and
South Dakota, for the disposal of low- level radioactive waste generated in each state. The
lack of a Low- Level Radioactive Waste ( LLRW) disposal site threatens the ability of LLRW
generators in the State to continue their work and may eventually affect public health and
safety. To provide for permanent disposal of low- level radioactive waste, Congress en-acted
legislation requiring states to assume this responsibility, either alone or through
interstate compacts. However, the Southwestern Compact, to which Arizona belongs, has
yet to develop its disposal site resulting in current and potential costs to Arizona LLRW
generators. Other alternatives for disposing of LLRW may exist if the proposed disposal
site in California remains undeveloped.
History of Low- Level
Radioactive Waste
Low- level radioactive waste consists of material contaminated by radioactive material
used in medical practice and scientific research, industrial processes, and nuclear power
plants. These contaminated materials include paper, rags, tools, protective clothing, labo-ratory
glassware, gloves, wood, and filters. For example, medical institutions produce
low- level radioactive waste by using radioactive elements to diagnose heart problems
and treat hyperactive thyroids. Universities generate low- level radioactive waste in can-cer
and AIDS research, drug testing, and carbon- 14 dating for archaeological and anthro-pological
studies. Many industries, including nuclear power plants, also produce this
type of waste.
The U. S. Nuclear Regulatory Commission ( NRC) regulates LLRW disposal and classifies
the type of LLRW disposed. Class A wastes, the least dangerous, comprise over 95 per-cent
of the volume of LLRW and will decay to acceptable levels in 100 years or less. Class
C waste, the most dangerous, must have additional physical safeguards to prevent envi-ronmental
or public harm.
In 1980, Congress enacted the Low- Level Radioactive Waste Policy Act that gave each state
the responsibility for managing and disposing its own low- level radioactive waste. The
act also encouraged states to enter multi- state compacts for LLRW disposal. Each com-pact,
upon receiving congressional approval, could limit LLRW disposal to generators
within the compact region, select a disposal site, and develop a disposal facility. Addi-tionally,
until states formed compacts and constructed disposal facilities, they could re-
tain access until December 31,1992, to the only three operating disposal facilities in the
country: Beatty, Nevada; Richland, Washington; and Barnwell, South Carolina.
In July 1988, Arizona joined California in forming the Southwestern Compact. North and
South Dakota joined the compact in 1989. Legislation designates ARRA as the Arizona
agency responsible for performing any administrative and enforcement duties assigned
to the State by the Southwestern Low- Level Radioactive Waste Disposal Compact. The
compact, governed by the Southwestern Low- Level Radioactive Waste Commission, des-ignated
California as the host state for its disposal facility. As a result, California con-tracted
with US Ecology, a private firm, to identify a site and develop a disposal facility.
Upon completing the necessary environmental studies, US Ecology selected a site on fed-eral
land in Ward Valley, approximately 22 miles west of Needles and the Colorado River.
On September 16, 1993, the California Department of Health Services ( CDHS) issued a
license to US Ecology for the construction and operation of a LLRW disposal facility in
Ward Valley.
Current Status of
Southwestern Compact
Although licensed by CDHS, US Ecology has been unable to construct a disposal facility
in Ward Valley. Several factors, including the U. S. Department of Interior's delay in trans-ferring
ownership of the land to California and various legal actions, have prevented US
Ecology from developing the Ward Valley site.
CDHS granted a license to US Ecology pending transfer of the Ward Valley land from the
U. S. Department of Interior, Bureau of Land Management, to California. California must
purchase the land from the U. S. Department of Interior to ensure full control and imme-diate
access should problems arise. However, the Secretary of Interior placed the land
sale on hold and requested a National Academy of Sciences ( NAS) review of issues raised
by the " Wilshire Report," a report prepared by three geologists employed by the U. S.
Geological Survey,(') which details concerns regarding the appropriateness of the Ward
Valley site. The NAS issued its report in May 1995 finding that the issues raised by the
Wilshire Report are not significant and recommending additional monitoring activities
for the site. California now awaits a federal decision on the land sale.
Also, opponents of the disposal facility are pursuing legal action in an attempt to prevent
its development. In a lawsuit filed in the State of California, opponents seek to void the
license granted to US Ecology based on US Ecology's questionable qualifications, CDHS'
failure to conduct proper hearings on the license, and locating a disposal site in an area
The Wilshire Report was written in 1993 by three geologists, Howard Wilshire, Keith Howard, and
David Miller, who acted as individuals rather than in official U. S. geological capacities. The geologists
prepared the report at the request of a California U. S. Senator.
designated as a critical habitat for the desert tortoise. Additionally, the Wilshire Report
was introduced into the lawsuit. The California Superior Court found that virtually all
issues raised by the opponents were without merit, but the Wilshire Report constituted
new evidence, and ordered CDHS to consider the report in the licensing process. Both
parties appealed and a decision is expected in 1995.
Impact and Alternatives
The delay in developing a disposal facility leaves few viable options for generators of
LLRW in Arizona. The most optimistic estimate would have the disposal facility con-structed
and operating by summer 1996; however, many stakeholders agree legal actions
could continue for many months, delaying the opening of a disposal facility until 1998 or
beyond. Since no authorized disposal facility is available, Arizona LLRW generators have
undertaken waste reduction efforts and/ or substituted non- radioactive materials where
feasible in their operations. Generators have also constructed temporary storage facilities
for waste storage until a permanent site becomes available.
While these actions do not offer a permanent solution for the disposal of LLRW, they buy
time for LLRW generators until a disposal site becomes available. However, LLRW gen-erators
have incurred significant costs to construct temporary storage sites and store waste.
For example, the consortium that operates the Palo Verde Nuclear Generating Station
recently completed construction of a $ 4.6 million LLRW temporary storage facility. Addi-tionally,
the University of Arizona will spend approximately $ 630,000 on a LLRW tempo-rary
storage facility, plus an estimated $ 15,000 in annual operational costs. LLRW genera-tors
in Arizona estimate they only have approximately five years of storage space avail-able.
In addition to the costs incurred for temporary storage, some LLRW generators fear a
direct impact on their operations if a disposal site remains unavailable. Research organi-zations
that use radioactive materials, including the University of Arizona, may have to
curtail research activities if there is no place to dispose of the waste. Organizations may
have, to devote some research dollars to finance temporary storage costs. Additionally,
important medical treatments and research may be negatively impacted.
The State can explore various permanent or temporary alternatives to the Ward Valley
disposal site, some with significant drawbacks.
Barnwell, South Carolina disposal facility opening - One alternative involves ship-ping
and disposing of LLRW at the Barnwell, South Carolina disposal facility. The
South Carolina Governor and Legislature recently enacted legislation that opened
Barnwell on July 1,1995, to all states, except North Carolina.(') Additionally, the South-
western Compact Commission issued a blanket approval authorizing generators within
the Southwestern Compact to export LLRW to this facility, if individual shipments
meet the terms of the approval. As part of its legislation, South Carolina will also
begin to explore new compacting arrangements. However, the Barnwell facility could
become a superfund clean- up site, meaning that liability for cleanup could extend to
the disposers of the waste. For this reason, the University of Arizona has not and
stated they will not dispose of their LLRW at Barnwell. Also, in September 1995, a
lawsuit was filed in South Carolina in an effort to reverse the legislation that opened
Barnwell to all states.
Arizona disposal or temporary storage site - Alternatively, Arizona might consider
developing its own disposal site or temporary storage site. However, these options
may be difficult to implement. First, Arizona must go through the same lengthy pro-cess
in siting a disposal facility and performing all the requisite environmental studies
as California. Additionally, Arizona would likely experience similar opposition. Sec-ond,
Arizona would be unable to restrict a disposal or storage facility to only Arizona
generators of LLRW. Such a restriction would violate interstate commerce laws. Ari-zona
generators also do not produce sufficient quantities of LLRW to entice a private
company to operate a disposal or storage facility. Such an operation would require
waste from additional sources outside the State.
Possible legal remedies - Finally, Arizona could seek legal remedies from Califor-nia
for its failure to develop a disposal site by January 1,1993, as legislated and agreed.
Arizona could either seek monetary damages or force California to accept the LLRW
generated in the State. Some stakeholders suggest that California might welcome such
a lawsuit as it might provide the additional impetus needed to counter opposition and
construct the disposal facility. Other stakeholders indicate that California is doing all
it can to build the facility and a lawsuit would be counterproductive and possibly
damage relations between the states.
South Carolina believes that North Carolina has not kept its agreement with the Southeast Compact to
construct an LLRW disposal facility. As a result, the South Carolina legislation denies access to Barnwell
to North Carolina generators of LLRW.
SUNSET FACTORS
In accordance with A. R. S. 541- 2954, the Legislature should consider the following 12 fac-tors
in determining whether the Arizona Radiation Regulatory Agency should be contin-ued
or terminated.
1. The objective and purpose in establishing the Agency.
In 1980, the Arizona Radiation Regulatory Agency ( ARRA) was established, replac-ing
its predecessor agency, the Arizona Atomic Energy Commission. The intent in
establishing ARRA is to reduce the risks to the public resulting from exposure to
radiation. Laws 1980, Ch. 206 51 state:
" It is declared to be the policy of this state to protect the public health and
safety by regulating ' the use and sources of radiation to provide far: ( 1) use of
methods and procedures relating to radiation which are demonstrated to be
safe; and ( 2) maintaining exposure to sources of radiation in amounts as low
as is reasonably achievable by means of good radiation protection planning,
practice and enfarcement. "
According to A. R. S. 530- 654. B ( 1) and ( 4), ARRA shall regulate the use, storage and
disposal of sources of radiation; and assume primary responsibility for and provide
necessary technical assistance to handle any incidents, accidents, and emergencies
involving radiation or sources of radiation occurring within this State.
2. The effectiveness with which the Agency has met its objectives and purpose
and the efficiency with which it has operated.
The Agency has generally met its objectives and purpose. To comply with its objec-tives,
the Agency licenses radioactive materials and registers all types of radiation
machines in the State. The Agency also inspects licensees and registrants. However,
we found that the Agency can do more to further safeguard the public health and
safety by:
Meeting inspection schedules for x- ray and mammography machines. The
Agency currently faces almost a 30 percent backlog in inspections for x- ray
tubes and a 77 percent inspection backlog for mammography tubes. ( See Find-ing
I, pages 5 through 13.)
Taking timely and adequate enforcement actions against radioactive materials
violations. ( See Finding 11, pages 15 through 22.)
ARRA has effectively responded to radiation- related emergencies and incidents
within the State. During the course of our audit, ARRA immediately and effectively
responded to a radiation incident in Tucson. Additionally, ARRA has performed
effectively during federal test exercises that evaluate the State's ability to respond to
radiation emissions from the Palo Verde Nuclear Generating Station.
3. The extent to which the Agency has operated within the public interest.
The Agency has generally operated within the public interest through its inspection,
emergency response, and environmental surveillance ( laboratory) activities. In ad-dition
to these activities, the Agency maintains a radon program that provides pub-lic
information to organizations and individuals, handles approximately 700 radon-related
inquiries per year, and provides ongoing assessment of potential radon haz-ards
in Arizona. However, the public interest could be better served if ARRA quickly
addressed its backlog of x- ray and mammography machine inspections and stayed
current with its inspection schedule. ( See Finding I, pages 5 through 13.)
4. The extent to which rules and regulations promulgated by the Agency are
consistent with the legislative mandate.
Rules and regulations promulgated by the Agency appear consistent with the legis-lative
mandate. Additionally, several articles are in various stages of development,
including an article to correct the rule discrepancy associated with the Agency's
ability to assess civil penalties. Despite these efforts, the Nuclear Regulatory Com-mission
( NRC) has cited ARRA for its failure to maintain regulations consistent with
NRC federal regulations as required by its agreement. The NRC noted this problem
in its June 1992 and March 1995 review of Arizona's radiation control program. ARRA
cites the State's lengthy rule- making process and insufficient staff to promulgate
rules as reasons for not maintaining rules consistent with NRC federal regulations.
5. The extent to which the Agency has encouraged input from the public before
promulgating its rules and regulations and the extent to which its has informed
the public as to its actions and their expected impact on the public.
The Agency appears to comply with open meeting law requirements regarding pub-lic
rules and regulation hearings. The Agency posts its meeting notices in a timely
manner and in accordance with the statement filed with the Secretary of State. Ac-cording
to the Agency Director, the Agency will revive a newsletter to inform the
public of proposed rulemaking actions.
6. The extent to which the Agency has been able to investigate and resolve com-plaints
that are within its jurisdiction.
Based on a limited review of consumer complaints received by the Agency, it ap-pears
that the Agency adequately investigates and resolves complaints. The Agency
reported receiving 14 complaints regarding its non- ionizing radiation program dur-ing
the past year and very few in its other program areas.
7. The extent to which the Attorney General or any other applicable agency of
state government has the authority to prosecute actions under enabling legis-lation.
According to A. R. S. 530- 685, the Attorney General has authority to make application
to the appropriate court for an order prohibiting any act that violates ARRA's stat-utes,
rules, or regulations. Additionally, the Agency has specific statutory authority
to assess civil penalties, impound radiation sources, and modify, suspend, or revoke
licenses. A. R. S. 530- 687. A requires the Attorney General to bring actions for collect-ing
civil penalties.
8. The extent to which the Agency has addressed deficiencies in the enabling
statutes which prevent it from fulfilling its statutory mandate.
Currently, the Agency perceives the inability of the State to order a person to clean
up an area that he contaminated, and that endangers the public health, as a statutory
deficiency. The Council of State Governments Suggested State Legislation for radia-tion
control programs recommends that states possess this authority. However, the
Governor can only order the State to remedy a contaminated area, not the person
who caused the public health problem. The Agency has proposed legislation ad-dressing
this concern in the past, but legislation has not been enacted.
9. The extent to which changes are necessary in the laws of the Agency to ad-equately
comply with the factors listed in the subsection.
Other then the inability of the State to order a person to clean up an area that he
contaminated, we identified no additional changes that are necessary in the laws of
the Agency to comply with the statutory requirement of protecting public health
and safety.
10. The extent to which the termination of the Agency would significantly harm
the public health, safety, and welfare.
Termination of the Agency could significantly harm the public health, safety, and
welfare. Radiation exposure poses considerable health risks, including cancer, ge-netically
determined ill- health, and developmental abnormalities. ARRA's regula-tion
programs including inspection, licensing and registration, emergency response,
and environmental surveillance serve to mitigate risks associated with radiation,
both man- made and naturally occurring.
11. The extent to which the level of regulation exercised by the Agency is appro-priate
and whether less or more stringent levels of regulation would be appro-priate.
Our review found that ARRA is not exercising appropriate regulation over licensees
and registrants. As discussed in Finding I ( pages 5 through 13) and Finding I1 ( pages
15 through 22), ARRA faces a large inspection backlog for registered x- ray and
mammography machines; and rarely takes enforcement action against licensees
with violations.
12. The extent to which the Agency has used private contractors in the perfor-mance
of its duties and how effective use of contractors could be accom-plished.
The Agency does not use private contractors in the performance of its primary du-ties.
Even though several states employ private contractors to perform inspections of
licensees and registrants, the Agency believes that privatizing the inspection func-tion
would not reduce the costs to the State for administering the program and would
likely lead to higher costs for the regulated community. According to radiation offi-cials
in Colorado, which has privatized inspections, privatization has proven cost-lier
for registrants, requires significant staff expertise to review reports and monitor
contractors, and has been difficult to implement. Colorado also reports that
privatization requires a sophisticated tracking system to ensure timely inspections
and information flow between the state, contractors, and registrants. Other states
and the Conference for Radiation Control Program Directors confirm this informa-tion.
The Agency does contract out for the analysis of its employees' film badges, which
are used to assess the radiation exposure of individuals who work near radiation.
The Agency also uses contractors for instrument calibration, specialized employee
training, and radiation source cleanup and disposal.
INTRODUCTION AND BACKGROUND
The Radiation Regulatory Hearing Board was established in 1980 to serve as a vehicle for
appeal by any person adversely affected by an order of the ARRA. The Board consists of
five members appointed by the Governor to five year- terms. The Board last met on Janu-ary
27,1993, and March 25,1993, to decide appeals of ARRA orders. The Board has not
met during fiscal years 1993- 94 and 1994- 95.
Given the infrequent nature of Board meetings and activities, our review was limited to a
review and preparation of sunset factors for the Board.
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SUNSET FACTORS
In accordance with A. R. S. 541- 2954, the Legislature should consider the following 12 fac-tors
in determining whether the Radiation Regulatory Hearing Board should be contin-ued
or terminated.
1. The objective and purpose in establishing the Board.
According to A. R. S. 530- 653 the Radiation Regulatory Board was established in 1980
as part of the act that also established the Arizona Radiation Regulatory Agency.
The Hearing Board provides a vehicle for appeal by any person adversely affected
by an order of the ARRA or its director. The Board may also review and make rec-ommendations
to ARRA and the Legislature regarding rules and regulations pro-mulgated
by ARRA, as stated in A. R. S. 530- 655. D.
The Board, which consists of five members appointed by the Governor, last met on
January 27,1993, and March 25,1993, to decide appeals of ARRA orders. The Board
has not met during fiscal years 1993- 94 and 1994- 95. This coincides with ARRA's
inability to assess civil penalties. Consequently, there has been no appeal of a civil
penalty, which would require the Board to meet.
2. The effectiveness with which the Board has met its objectives and purpose
and the efficiency with which it has operated.
According to the Board, it has reviewed appeals in a timely manner, and in the
majority of cases, affirmed ARRA's decision. In some cases, the Board has modified
the amount of civil penalty assessed; however, the Board has never revoked an or-der
of the agency. Additionally, no Hearing Board decisions have been appealed to
the Superior Court. Finally, the Board reviews and comments on draft rules and
regulations proposed by the Agency.
Based on our review of Board decisions since 1990, we found that it had reduced
three civil penalties ordered by ARRA. In other instances, the Board upheld the or-der
of ARRA. Also, the Board rendered its decisions within approximately four to
eight months following appeal.
3. The extent to which the Board has operated within the public interest.
The Board believes it acts in the public interest by providing an appellate review of
ARRA enforcement actions. The Board's independence and action in the public in-terest
are demonstrated in those cases where the Board has reduced a proposed civil
penalty.
4. The extent to which rules and regulations promulgated by the Board are con-sistent
with the legislative mandate.
Since the Board only performs an appellate function, it does not promulgate rules
and regulations.
5. The extent to which the Board has encouraged input from the public before
promulgating its rules and regulations and the extent to which its has informed
the public as to its actions and their expected impact on the public.
The Board does not promulgate it. own rules and regulations.
6. The extent to which the Board has been able to investigate and resolve com-plaints
that are within its jurisdiction.
The Board does not receive complaints from consumers.
7. The extent to which the Attorney General or any other applicable agency of
state government has the authority to prosecute actions under enabling legis-lation.
The Board has no enforcement authority.
8. The extent to which the Board has addressed deficiencies in the enabling
statutes which prevent it from fulfilling its statutory mandate.
The Board has not proposed any changes to its enabling statutes.
9. The extent to which changes are necessary in the laws of the Board to ad-equately
comply with the factors listed in the subsection.
We did not identify any changes that are needed in the Board's enabling legislation
to adequately comply with the Sunset Factors.
10. The extent to which the termination of the Board would significantly harm the
public health, safety, and welfare.
Terminating the Board would not harm the public health, safety, or welfare. How-ever,
the Board appears to provide a check and balance on the actions of the agency
and provides a timely, less expensive alternative to court actions.
11. The extent to which the level of regulation exercised by the Board is appropri-ate
and whether less or more stringent levels of regulation would be appropri-ate.
This factor does not apply because the Board has no regulatory functions of its own.
12. The extent to which the Board has used private contractors in the performance
of its duties and how effective use of contractors could be accomplished.
The Board uses private hearing officers to conduct hearings on appeals of ARM
actions. The full Board then acts on the recommendations of the hearing officer.
Contracts for hearing officers are handled through the Department of Administra-tion.
According to the Board, this mechanism has proven to be effective.
( This Page Intentionally Left Blank)
Agency Response
Arizona Radiation Regulatory Agency
@ I~@ NA RADIATION REGULATORY AGENCY
4814 South 40 Street Phoenix, Arizona 85040
Fife Symlnoton
Governor
Aubrey V. Godwin
( 602) 255- 4845
FAX ( 602) 437- 0705
October 19, 1995
Douglas R. Norton
Auditor General
Office of the Auditor General
2910 North 44th Street, Suite 410
Phoenix, AZ 85018
Dear Mr. Norton;
Thank you for the opportunity to respond to the Draft Report of the performance audit of the Arizona
Radiation Regulatory Agency. We appreciate the professionalism exhibited by the audit team during the
review process. They should be commended for their grasp of the many technical issues facing the Agency.
Due to the highly technical nature of this program, I request that the enclosed Conference of Radiation
Control Program Directors' " Review of Radiation Control in Arizonan be attached to this report. Even though
referenced in our response, I am not requesting that the U. S. Nuclear Regulatory Commission review and
evaluation, dated June 7, 1995, be included with the report but to be available on request.
We have some comments which should be associated with and attached to the report to give the reader a
better perspective of the Agency operations and perhaps clarify the information in the report. These comments
are as follows;
1. We believe that it would be clearer to the readers if the report did not intermingle the situation at the
time of audit with the current status without specifying which period is applicable. For example on
page 2 of the report, the FTEs listed for X- ray, Mammography, and Non- ionizing Radiation are
7.5. Actually, during the period audited by this report, the Agency was authorized only 6.5 FTEs for
x- ray, mammography, and non- ionizing program. The 7.5 became effective on July 1,1995, after the
audit portion was closed.
2. The data presented in this paragraph were calculated for a period prior to the end of the audit portion
of the review. Although close to the end of the review, had the data been corrected for the end of the
review period, it would have shown 76.0% overdue by one year and 34.5 % overdue by two or more
years. As of October 1, 1995 the percentages are 55.3% and 34.1% respectively. We believe that
these changes in percentage overdue support the actions identified by Agency management, and the
Conference of Radiation Control Program Directors. Some of these are the same as identified by the
Auditor General while others are more technical.
3. Figure 1. on page 8, does not indicate that the Paid Leave includes 5 % for legal holidays and 6% for
coffee break time. Further, all state employees are authorized 4% of the year as annual leave. Many
time studies leave out coffee break time.
4. The last paragraph on page 8 does not recognize that the employee involved was the " lead inspectorn
Douglas R. Norton
October 19, 1995
Page 2
and had some supervisor/ managerial responsibility. It is within management's authority to assign
management activities to subordinates, otherwise, since a given manager is responsible for all
activities under their control, he could not ask any subordinate to perform any activity. Management
recognized the difficulties associated with this arrangement and began discontinuing this practice prior
to the Auditor General's review. The use of " lead inspectors" was necessitated by the reduction in
managerial staff in the Agency and the subsequent reorganizations.
The Auditor General's Report appears to have a total lack of recognition that even though staffing is
limited, the total administrative workload for approximately 8,000 x- ray tubes remains the same, and
must be performed by the few available staff. In fact in 1985 when the last Auditor General's Review
was conducted, the Agency had 4 x- ray inspectors for 5,632 tubes. Since 1985, the number of x- ray
tubes has increased to 8,125 or a 44% increase by 1995. During the same period the inspection
staffing increased 20 % . The additional inspector was for the Mammography program funded by the
U. S. Department of Health and Human Services. The Agency was behind in its x- ray inspection
program in 1985 and has not received the resources to catch up. The Conference of Radiation Control
Program Directors in their criteria for x- ray programs indicate that smaller programs have an
increased administrative workload per inspector. In their 1995 review, page 5, clearly recognized that
smaller staffs have to spend more time per person on administrative duties than large staffs by quoting
the range of FTE/ 1,000 x- ray tubes. The 1.4 FTE/ 1,000 x- ray tubes is for the large staff and the 2.1
FTE11, OOO x- ray tubes is for the small staff. Further, for FY 1989 to FY 1993 the staff available to
the Agency was reduced each year, which limited trained support and technical staff within the
Agency.
5. The last sentence of this paragraph ( on page 9) appears to be based on information supported by the
discussion in the next paragraph. Unfortunately, the reviewers did not recognize that the power line
siting actions are a part of the non- ionizing radiation management duties nor that the Low Level
Radioactive Waste activities are a part of the radioactive material management duties. These are the
primary duties of this individual and he is not in a position to pick and chose about performing them.
Agency management has recognized that this particular manager was over tasked and is taking steps
to correct the situation.
6. The third full paragraph on page 9 indicates that technical staff time is wasted on registration. The
paragraph does not recognize that the registration by non- technical staff resulted in significant errors
in the records and has increased the time required by the technical staff to correct the errors. The
Agency has moved data in- putting to the administrative staff.
7. The last paragraph on page 9 is quite correct when the Auditor General recommended that we use
temporary help for processing the fees. As a matter of fact, both the Agency and the Medical
Radiological Technology Board of Examiners used temporary staffing January 1995 which is not
mentioned in the report.
8. On the top of page 10, omitted in these statements in the first paragraph is, currently management
does hold the inspectors accountable for the quantity and quality of work. Further, during the period
reviewed, initial steps were being taken by the current management to identify the problem and
establish performance goals. The ability to receive a pay raise is directly tied to the performance of
Douglas R. Norton
October 19, 1995
Page 3
each individual inspector.
We have suggested that calendar 1994 is a better indicator than FY 1994 data for several reasons. A.
Several of the inspectors had less than one year experience as an independent inspector during this
period. Indeed, two had not completed their training to be independent inspectors. B. One inspector
was phasing into non- ionizing radiation, and while not included in the table, did influence the
activities of the x- ray program.
9. The last paragraph on page 10 indicates that one employee is not being held accountable for his
actions and that his performance evaluations do not reflect the worker performance. Contrary to the
statements in the report, the individual's performance was graded below standard in 1995 and 1992
for several areas of work. Management was careful to document the quality of work and base the
performance evaluations on the documentation rather than contemporaries opinions in order to
preserve the individual's civil and employment rights. See also response 8. above.
10. Notwithstanding the comments in the first full paragraph on page 11, A. R. S. 623- 408 C. clearly states
that notice of an intended inspection shall not be given to an employer prior to the time of actual entry
upon the workplace. While it is true the interagency agreement does not address this point
specifically, it is clear that the Director of the Division of Occupational Safety and Health did not
grant an exemption to this portion of the statue. Further, in other states, the U. S. Occupational Safety
and Health has determined that occupational inspections should be unannounced. The basis of the
selection of the states listed is not clear to this point, for example, does each state have an
occupational safety and health program approved by the U. S. Department of Labor? Is the Radiation
Control Program a portion of that agreement?
The experience of the director in another state radiation program which performed both scheduled and
unannounced inspections, is that for the inspectors time it makes no difference which is used. This
is due to;
A. The inspector must take time to call and set inspection appointments, attempting to get
them in close proximity with each other.
B. For a significant number of the appointments, the facility is not ready for the inspector
due to patient considerations.
C. When scheduling appointments, some extra time must be allowed so that when a
problem arises, the inspector will not be late for the next appointment.
D. When appointments are made, if a problem occurs, the inspector is pushed to ignore
or the rush through the problem rather than taking the time to resolve the problem
correctly.
E. On occasion a facility has refused to set an appointment for an inspection.
11. The Auditor General's Report glosses over the effects of the differences between states in their
Douglas R. Norton
October 19, 1995
Page 4
compliance programs. The differences are very significant in the number of inspections per inspector.
In assessing the appropriateness of the states selected in Table 3, the Auditor General's Report does
not indicate how many support staff these states legislatures have authorized for these programs; the
ratio of each type of x- ray tube usage to the total number of x- ray tubes; the computer support
available; any independent review of these states inspection programs to assure that the regulations
are being followed. Without this and similar data it is impossible to conclude that the information is
comparable with Arizona. In fact, 30% of the states contacted by the Auditor General apparently
consider inspection performed per year per inspector to be such a poor basis for judging performance
that they do not even track the number of inspections performed by each inspector, Maryland,
Colorado, and Oklahoma.
12. The Nuclear Regulatory Commission review did not indicate any problems with slow enforcement.
Specifically, 2. and 4. of Enclosure 2 and 21., 22., and 23. of Enclosure 3 of that review do not
indicate any problems with our enforcement actions. Further, the Nuclear Regulatory Commission
review did not find a problem with our follow up on non- compliances.
Thank you again for this opportunity to respond.
S& inc;&< e! re, l,, yY' / A1
Aubrey V! ~ odwin
Director
ENC
Review of
Radiation Control in Arizona
by the
Conference of Radiation Control
Program Directors, Inc.
August 1995
Prepared and published by the
Office of the Executive Director
CRCPD, 205 Capital Avenue
Frankfort, Kentucky 4060 1
Phone 5021227- 4543
Table of Contents
Page
Executivesummary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Bases of Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Detailed Findings and Recommendations
X- Ray and Radioactive Materials Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Non- Ionizing Radiation Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Environmental Monitoring Program and Laboratories . . . . . . . . . . . . . . . . . . . . 13
Emergency Response Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Members of the CRCPD Review Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Persons Interviewed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Executive Summary
The Conference of Radiation Control Program Directors, Inc., ( CRCPD) is a professional
association for governmental radiation control program personnel in the United States and Canada
The CRCPD promotes adequate, uniform control of radiation hazards. As one of its services, the
CRCPD will review the radiation control program of a state and recommend improvements.
The Director of the Arizona Radiation Regulatory Agency ( ARRA) requested, in May 1995, a
comprehensive review of radiation control in Arizona. A team of six volunteers from state and
federal radiation control programs, and one CRCPD staff person, was promptly enlisted to carry
out this review. The team reviewed the statutory basis for the program, the forms and procedures
used, information retained in the files, and interviewed staff and legislators June 25- 30.
The review of radiation control in Arizona found the program to be quite well developed by
professional standards, active, and well equipped except as noted in the following findings.
The empowering legislation is comprehensive of all types of radiation, and lacks only provisions
for the emergency impoundment of sources and for the certification of radioassay laboratories.
The regulations for radiation control conform to the requirements for the federal programs with
which Arizona is involved and to the Suggested State Regulations. Unfortunately, Arizona's
process for regulation adoption, even for improvement of a radiation source registration form, is
entirely too cumbersome to maintain compliance with the ever- changing federal requirements and
to be responsive to new information on radiation hazards. Also, the few revisions should be made
to meet the requirements for CRCPD recognition of the Arizona licensing of naturally occurring
and accelerator produced radioactive materials. This is a national program that enhances the
uniform and adequate control of these materials, and it provides for reciprocal recognition of
licenses at considerable cost savings to both the licensee and the regulatory agencies.
The management plan for the ARRA, with a scope of five years, should be updated annually to
defme goals, utilize resources, assure coordination among the components of government that
have responsibility for radiation control, and stem the continuing loss of qualified staff.
More numerous state position categories and pay grades are sorely needed in the ARRA. The
ARRA inspectors and clerical staff need relief from the burden of fee collection. They must
instead give more attention to legally sound documentation of their radiation control activities.
Priority should be given to enhancing inspection, guidance to users, and enforcement of
regulations on medical x- ray because this is by far the largest source of exposure to man- made
radiation and for which the largest reduction of unnecessary exposure can be accomplished.
Detailed recommendations for actions by the legislative and executive branches of government,
and the radiation control program of Arizona government are provided in this report.
Introduction
The Conference of Radiation Control Program Directors, Inc., ( CRCPD) is a professional
association for the staff of govemment radiation control programs throughout North America.
The objective of the CRCPD is to promote adequate, uniform control of radiation hazards.
One of the services of the CRCPD is, upon request by a state, to review the radiation liaz& ds and
the radiation control program in that state, and to recommend improvements in regulation and
control. Following such a request, the CRCPD Executive Director assembles a review team that
consists of technical staff of relevant federal agencies and their regional offices, a director of the
radiation control program in another state, and staff of the CRCPD Office of Executive Director.
This team interviews members of the radiation control program and other persons involved with
the use or the control of radiation. The on- site review concludes with a presentation to state
govemment officials of a summary of the significant findings and recommendations. The review
team then prepares a detailed written report which is submitted to the director of the radiation
control program.
The Director of the Arizona Radiation Regulatory Agency, in May 1995, requested a
comprehensive review of the radiological health program in Arizona On- site interviews were
conducted during the week of June 25- 30, 1995.
The aspects of radiation control that were reviewed were x- ray, radioactive materials, low- level
radioactive waste, indoor radon, environmental surveillance, nuclear safety, emergency response,
contaminated sites, non- ionizing radiation, and administration of the radiation c. o. n trol program.
The recommendations were based on information in the following documents:
Council of State Governments, 1983, Suggested State Legislation, Radiation Control Act.
Conference of Radiation Control Program Directors, 1991, Suggested State Regulations for Control
of Radiation, 8th edition
Conference of Radiation Control Program Directors, 1981, Criteria for Adequate Radiation Control
Program, X- Ray
Conference of Radiation Control Program Directors, 1982, Criteria for Adequate Radiation Control
Program, Radioactive Materials
Conference of Radiation Control Program Directors, 1985, Criteria for Adequate Radiation Control
Program, Nonionizing
Conference of Radiation Control Program Directors, 1986, Criteria for Adequate Radiation Control
Programs, Environmental Monitoring and Surveillance
Conference of Radiation Control Program Directors, 1990, Criteria for Adequate Radiation Control
Programs, Radon
CRCPD Recognition of Licensing States for the Regularion and Control of NARM, 1994
Arizona X- Ray and Radioactive Materials
Program Review
Narrative Report
An assessment of the population radiation exposure, made by the National Council on . Radiation
Protection and Measurements ( NCRP 93) in 1987, found- that uses of radiation in the he& ng arts
represent approximately 83% of the total man- made exposure to the U. S. population. In contrast,
occupational exposures were less than 2% and exposure to the entire nuclear fuel cycle was less
than 0.5% of the total man- made exposure. Not only is diagnostic x- ray by far the single largest
source of exposure to man- made radiation, it is also the source for which the biggest dose
reduction gains in man- made exposures can occur without having a negative impact on the
benefits for the public.
The review of the x- ray program revealed that the Arizona statutes ( especially Title 30 Chapter 4,
Section 651, et seq. last amended in several ways in 1992) provide for a program that is
consistent with that suggested by the Criteria for an Adequate Radiation Control Program.
Therefore the limitations of the program are the limitations of resources and perhaps design rather
than statutory. The regulations were last updated in 1986; further modifications to update these
regulations are difficult because of increasingly arduous procedures established by the legislature
( 1995 changes to the Chapter 251 have further complicated the process). The current process
requires not only the typical public process of rules promulgation, but there are now two review
groups involved as well, one at the Governor's level ( the Governor's Review Council) and one at
the legislative level ( the Administrative Rules Oversight Committee). The result is that even more
personnel resources than would be normal must be applied to this aspect of managing the
radiation control program. Periodic adjustments in the regulations are necessary for several
reasons, some will be the result of needs internal to the radiation control program but perhaps
most are external forces that must be accommodated, e. g. new sources of radiation, new
procedures or changes required by federal law.
A note of caution, ( an item not discussed during the exit interview) - it appears
that some program vulnerability may result from potential uneven regulatory
practices. The 1995 changes in the administrative rules section of the Arizona
statutes suggests a reduced burden of proof necessary for a complainant to receive
a financial award against the Agency. The complaint could be a simple one
suggesting that the agency's regulatory requirements were more strictly enforced on
his operations than they were on another facility. Since the Agency's " practice or
substantive policy statement" ( sec. 41- 1030 and 41- 1033) are held in the same light
as formal rules, it appears that all actions of the Agency are made much easier to
contest and subject to feelcost recovery from the Agency's operating funds.
The opinions formed about the x- ray and radioactive materials programs as recorded here are the
result of a review of the statutory basis for the program; a review of the forms and procedures
used in registration/ licensing and inspections; information retained in the files; and interviews with
several of the staff and management. No attempt was made to evaluate the quality of the
inspections by accompanying the inspectors during an actual inspection, nor was any attempt
made to evaluate the inter- inspector consistency of inspection except through reviews of the data
in the inspection reports and compliance letters currently being issued.
Findings and Recommendations
X- ray and Certification Program
The Arizona x- ray program has the normal inspection and compliance functions. The Agency
also has the Medical Radiologic Technology Board of Examiners ( MRTBE), who manage the
certification of ionizing radiation machine operators other than dental hygienists. The MRTBE is
currently staffed by two persons, a professional FTE and a clerical assistant, The MRTBE staff is
able to maintain ( with difficulty) pace with the applications for certification and renewals of the
currently 3,500 registered x- ray technologists in the State. Clearly this is possible because of the
strategy of utilizing the examinations of the American Registry of Radiologic Technologists
( ARRT). Although authorized to develop other tests, the MRTBE believes that this is the fairest
since the ARRT has had a psychometrician validate all of the questions used as appropriate for
the profession. Although dated, the Agency has copies of past examinations which could be used
if the ARRT examination were unavailable. The prime workload of the MRTBE staff appears to
be routine review of applications and assuring the renewal of certificates. Much of the work is
devoted to responding to routine telephone calls from technologists who have not completed
applications within the required time frames. A significant portion of the professional FTE is
devoted to receiving and investigating complaints about illegal or unethical conduct. Because of
the workload, there is little room for difficulties in the program. Should the staffing become
compromised, the impact on technologists and on public health and safety would be appreciable
because of not only expiring certificates but the potential for uncertified practitioners.
The X- ray inspection and compliance group is currently staffed at 4 FTE's and is responsible for
8,198 tubes in 3,574 facilities. An additional FTE is dedicated to mammography inspections
under FDA contract. The program manager must split his attention between the x- ray program
and the radioactive materials program.
Radioactive Materials Program
Arizona regulates certain of the radioactive materials covered by the federal Atomic Energy Act
under an agreement with the Nuclear Regulatory Commission ( NRC). Because the NRC
completed its last program review of Arizona in March 1995, the CRCPD review team did not
focus on the licensing and inspection activities that are evaluated during the NRC evaluation.
The periodic reviews of the materials program by the NRC have been effective in maintaining the
adequacy of the radioactive materials program. However, until this CRCPD review, there has
been no outside, systematic, peer review of the x- ray program. " Sunset review" of the overall
program was recently completed; however, no information about the findings were available. A
previous sunset review occurred in 1985.
Recommendation # 1
CRITERIA: A radiation control program should have adequately trained staff to provide the
necessary professional service for a comprehensive program in radiation protection. The x- ray
program should have between 1.4 and 2.1 professionaVtechnical FTE per 1,000 tubes.
FINDINGS: Recent staffing restrictions have made a poor staffing situation in the x- ray
inspection and compliance program even worse. Inspection reports do not document that all
appropriate sections of Arizona's regulations are being met, nor would they be able to withstand a
legal challenge.
In addition to the problems cause by under- staffing, the x- ray program has lost a management
position. The technical demands, diversity and differences between the x- ray program and the
radioactive materials program is such that one person has difficulty overseeing both programs.
While the existing staff are reasonably well trained, they seem overwhelmed with the workload.
Pressures to increase the inspection rates to levels of 500 tubes per year for each person are not
realistic for the inspection frequencies and the mix of x- ray facilities found in Arizona
The inspection routine has been modified, as a result of severe under- staffing to the following
frequency ( CRCPD recommendations provided for comparison):
Current CRCPD
Arizona Frequency Recommended Frequency
Hospitals 2 years Hospitals 1 year
Radiology clinics 2 years Radiology clinics 1 year
Other medical 3 years Other medical 2 years
Dental 4 years Dental (! 4 visited) 5 years
Industrial 4 years Industrial 2- 4 years
Recommendation # 1 II
Arizona should have 14 professionaVtechnicaI FTE and 3 clerical FTE to support a
comprehensive x- ray inspection and compliance program with facility inspection
frequencies approaching those suggested by the CRCPD. At least one additional
FTE supervisor/ manager is required.
COMMENT: The current staffing levels prevent the Agency staff from providing facilities with
the kind of assistance that would improve the recognized benefits of medical x- ray procedures.
As one example, it appears that no attention is being paid to the objective evaluation of film
processing techniques even though the procedures have been readily available to the staff for
several years though the CRCPD Nationwide Evaluation of X- ray Trends ( NEXT) program.
The CRCPD frequencies cannot be met by Arizona without significant additional resources. The
staffing levels recommended by the CRCPD ( note the special approach to dental facility
inspections) to achieve the recommended frequency would require approximately 17 FTE
( including 3 clerical FTE). In addition to providing the recommended inspection frequency, this
staffing level would also afford the opportunity for the inspectors to provide the facilities with
help in improving the quality of the radiological practices in many of the same ways currently
required by the Mammography Quality Standards Act.
Adequate clerical support would free up the professional/ technical staff to concentrate on the
health and safety issues rather than registration issues.
Recommendation # 2
CRITERIA: The day- to- day operations of the x- ray and the radioactive materials programs
should each be guided by their overall written management plans of the respective programs.
The plans should be based on data showing the extent to which workers and patients are exposed
to sources of radiation. The long and short term objectives should be established with specific
targets for priority and accomplishment. The plan should include periodic evaluation of program
effectiveness and a method to demonstrate the changes in exposure to the workers and public that
have occurred.
FINDINGS: Cunently the program operates on a basic management plan that is known by the
individuals involved but appears to be limited to inspection goals ( i. e. numbers of inspections
completed). The plan is only short term, that is, it is based on recent changes in regulations and
the need to inspect facilities against new rules. Measures of program effectiveness are limited to
1) statistical accounting of the numbers of inspections by county and type of practice; 2) some
notations about whether or not the facilities have been found to be in ( presumably significant)
non- compliance; and 3) recently by the addition of inspection quotas as part of the staff's
employee evaluations. While some information is often obtained during inspections of x- ray
facilities regarding the exposures received by patients from typical types of x- ray examinations, no
attempt has been made to compare this information to national averages which are routinely
published by the CRCPD, nor to present- this information in a public way.
Perhaps the most important impediment to developing an overall management plan for the two
programs is the lack of an effective and responsive data management program ( see below). The
current program is admittedly incomplete, however the inspection staff seem to want to return to
the " simple, old days" with a familiar but extremely limited data base system that could not be
easily modified for changes in the inspection process, nor could it be the kind of effective
program management tool required by modem management methods.
COMMENT: Operational plans should be developed. The registration, licensing and inspection
criteria should be grounded on public health and safety. These documents should be derived from
a series of management retreats with staff to clearly identify achievable goals. The plans should
be translated into individual personal goals and personal development plans. Staff training should
be part of the plan.
Recommendation # 2
Operational plans should be developed for the x- ray and radioactive materials programs.
The plans should include the following basic components: The problems; objectives;
methodologies; and evaluation. An inspection schedule should be developed
semiannually. The inspection frequency should be based upon the hazard and the
inspection history.
A written program plan with goals and objectives agreed upon by staff and management would
help to bring staff and management together in planning and priority setting so that the goals are
practical for them to achieve. There should be periodic staff meetings so that priorities can be
shifted if necessary to meet short- term goals. Potential short- falls can be identified in a timely
manner, and course corrections can be made before anyone goes too far away from the overall
direction.
-
If the goals are not coincident with staff career goals, then it will be clear that staff should
consider changing their position.
Recommendation # 3
CRITERIA: The RCP should be organized with the view toward achieving an acceptable
degree of staff efficiency, and placing appropriate emphasis on major program functions. It
should have adequate secretarial and clerical support.
FINDINGS: It is the practice of the program to be responsible for the billing and. colleeiion of
the fees charged radiation source registrants. This includes all aspects except the actual
maintenance of the funds in an account. At times, the program must hire temporary staff to
support the billing process. Since the funds are placed in the State treasury and are not available
to the program for use, there is no need for a separate account. At the same time, the effort
required by the staff to issue the bills and track payment and collection takes away from the staff
time available for the more important ( from a public health perspective) inspection and
compliance activities. While the program must continue to be involved in this activity because of
the need to assure accuracy in the billing process, there is no need for the staff to be responsible
beyond the most minimal activities required to assure accurate billing data transfer to a separate
billing and collection function.
,
Recommendation # 3
Effort should be made to minimize the radiation control staff workload requirements
to support the fee billing system. Alternatives to the current system should be
identified that are consistent with Arizona law and with the collection practices of the
State.
COMMENT: The current system not only requires the technical staff to accomplish
administrative functions significantly different from those necessary for their primary inspection
and compliance functions, it also requires an additional, if small, audit requirement on the
administrative support functions of the State. By combining the collection and audit functions
with other similar programs, administrative oversight and auditing requirements should be reduced
to an appropriate minimum. As with most States, the fees collected by the program have no
positive fiscal impact on the program and therefore no fiscal incentives for timely collection
management.
Recommendation # 4
CRITERIA: The Radiation Control Program should have a data management system that
provides an objective means for evaluating and demonstrating the public health and environmental
impacts of the program. It should also provide the data that is necessary for program planning,
evaluation, and efficiency. Statistical data from inspections should be developed to permit
program management to assess the status of the program on a periodic basis.
FINDINGS: The x- ray and radioactive materials programs previously used a data based program
to track licensing and compliance. The information provided by the computer program had been
based on input from staff. Because the old program was difficult to modify, and because it did
not contain necessary information or allow for the relational analysis to other data information
systems necessary for a modem regulatory program, a decision was made to convert and modify
the program to dBase IV. The new system is being programmed by a person( s) outside of the
agency. It does not function as desired or as necessary.
The fact that the program does not function properly has led to frustration. Additionally, some
staff do not appear to accept the need for an information system of the type that allows
comprehensive planning and evaluation of program activities that are necessary to achieve
efficiencies, or to justify program activities.
The program did have one FTE available for computer programming, but that position had been
eliminated.
Recommendation # 4
A functional management information system should be developed that will permit
the evaluation of 1) regulatory activities; 2) program effectiveness, e. g., patient,
worker and public dose assessments; and 3) program efficiency and consistency.
COMMENT: An integrated, flexible management information system is necessary in a
modem program in order to document the program's activities, to simplify administrative
procedures, and to obtain the data that is required to identlfy needed changes in program direction.
Before an adequate Operational Plan can be developed ( see above), a modem information
management system must be made available.
The Radiation Control Program should obtain the services of a data management system planner
to optimize the use of their computers. The development of an effective data management system
will be difficult unless the staff supports such a program and are committed to the utilization of
such a system once in place. As part of the development process, both management and staff
must evaluate what information is needed for the program to protect public health and safety in
the most effective and efficient manner. The system must be developed in a manner which
permits not only the current information needs of the program to be easily obtained by the staff,
but it should provide for easy updates and frequent and unique reports.
Statistical data from inspection and licensinglregistration activities should be developed to permit
the analysis of the status of the agency's programs on a periodic basis. A mechanism should be
established for periodic, detailed reporting of achievements and shortfalls, based on monthly
reports. The report of program activities should be widely circulated to enhance communications
within the agency, and with outside agencies and customers.
Recommendation # 5
CRITERIA: The x- ray program should have written procedures to insure that uniform inspections
are conducted. Inspections should be capable of determining whether a facility is in compliance
with the agency's regulations.
BINDINGS: The x- ray inspection reports do not document that facilities ' are in cornphnce with
all applicable regulations. Additionally, items that could improve image quality and reduce patient
exposure do not appear to be evaluated. For example:
While some reports reviewed had information about exposure rates in areas adjacent areas,
one of the survey meters used was not calibrated since 1993.
Reports did not document whether or not the facility had an ALARA program subject to
annual reviews.
It appears that no attention is being paid to the objective evaluation of film processing
techniques during routine inspections of all facilities.
Recommendation # 5
Inspection reports should be modified to assure inspection uniformity and to assure facility
compliance with regulations.
COMMENT: The inspections currently are rather basic and have not kept up with current
practices. Consistent and comprehensive inspections are needed to ensure that public health is
protected and that all facilities are being treated in a uniform manner. Additionally, data about
patient and radiation worker exposures could be collected and used to identify program
accomplishments, trends and needs.
Recommendation # 6
CRITERIA: The Radiation Control Program shall have regulations essentially in conformity with
the Suggested State Regulations for the Control of Radiation. Further, it is the Conference position
that States should obtain Conference recognition as a NARM Licensing State.
FINDINGS: While a detailed evaluation of Arizona smtes, regulations and procedures was not
conducted relative to the Licensing State criteria, it appears that Arizona should be able to meet
the Licensing State criteria It was determined that the state has not developed criteria relative to
allowing NARM from non- Licensing States into Arizona
The ARRA should initiate the necessary steps
to become a Licensing State.
COMMENTS: There is no federal or other uniform- regulation for the use of naturally
occurring or accelerator produced radioactive materials ( NARM). As a result of non- uniform
regulation of NARM, difficulties have developed for those states that have attempted to regulate
NARM. This creates potential public health and occupational safety consequences. Specifically,
states wishing to license NARM sealed sources/ devices manufactured in another state for which
there has been no validation of NARM licensing criteria or authority find it is difficult, if not
impossible, to license such items other than to issue a single license for each individual source or
device. Except for the Conference recognition of a State for the licensing of NARM, there is no
mechanism for the reciprocal recognition of a license to manufacture, since no validated license
exists. Likewise, there is no basis to accept, under reciprocity, a NARM licensee from another
state.
If Arizona obtained Conference recognition for the licensing of NARM, it would enable its
NARM licensees to work in other Licensing States under reciprocity. It would also provide the
program with a basis for evaluating requests for NARM source approval and reciprocity from
other states.
Arizona Non- Ionizing Program Review
Narrative Report
The CRCPD has published guidance for States in establishing an adequate program for the control
of hazardous sources of non- ionizing radiation, and the review team recommends thq this
guidance be followed. However, the review of this progam area in Arizona is listed io h e
varied experiences of the review team members.
Arizona's regulatory authority to control sources of non- ionizing radiation stems from the Title 30,
Chapter 4 sections authorizing other aspects of the program. The regulations controlling sources
of nonionizing radiation are found at Title 12, Chapter 1, Article 14 of the Arizona Administrative
Code. The sources specifically covered by regulation include laser sources, RF sources and
sources of ultraviolet radiation produced by electronic products. The statutory authority and the
regulatory framework appear to appropriately cover these sources and if these standards are
enforced will help to assure Arizona residents of protection from unnecessary and hazardous
exposures.
The staff